Get the free APO-8284 Fingertip Pulse Oximeter FDA 510(k) Files - accessdata fda

This document provides a summary of safety and effectiveness information for the APO-8284 Fingertip Pulse Oximeter, submitted to the FDA for premarket notification.

How to fill out apo-8284 fingertip pulse oximeter

How to fill out APO-8284 Fingertip Pulse Oximeter FDA 510(k) Files

1. Gather all necessary documentation including device description, intended use, and clinical data.
2. Prepare a summary of the safety and effectiveness of the APO-8284 Fingertip Pulse Oximeter.
3. Include labeling information, such as instructions for use, indications, and contraindications.
4. Compile any performance testing results, including accuracy and reliability data.
5. Complete the 510(k) application form, ensuring all required sections are filled out accurately.
6. Submit the application electronically, making sure to comply with FDA submission guidelines.
7. Pay the appropriate user fees as stipulated by the FDA.
8. Respond promptly to any requests for additional information from the FDA during the review process.

Who needs APO-8284 Fingertip Pulse Oximeter FDA 510(k) Files?

1. Manufacturers of the APO-8284 Fingertip Pulse Oximeter seeking to market their device in the United States.
2. Regulatory affairs professionals ensuring compliance with FDA requirements.
3. Healthcare providers looking to obtain FDA-cleared oximeters for clinical use.
4. Researchers requiring FDA clearance for studies involving the device.

People Also Ask about

Which pulse oximeters are FDA approved?

The manufacturer Masimo's MightySat Medical became the first FDA-cleared medical fingertip pulse oximeter available OTC product in February 2024.

Is Walgreens pulse oximeter FDA approved?

Other pulse oximeters worth considering If you're looking for an inexpensive pulse oximeter that you can pick up in a store, quickly: The Walgreens Fingertip Pulse Oximeter is a widely available device with an easy-to-read display. It's listed for recreational use only and has not been cleared by the FDA.

Is the oxiline pulse oximeter FDA approved?

The Pulse 9S Pro is an FDA-cleared pulse oximeter. It's easy to use and provides consistently reliable readings thanks to its built-in VTEC technology.

What brand of oximeter do hospitals use?

Masimo SET® is used in all care areas of the hospital and beyond.

What pulse oximeter is FDA approved?

The manufacturer Masimo's MightySat Medical became the first FDA-cleared medical fingertip pulse oximeter available OTC product in February 2024.

What is a 21 CFR 870.2700 oximeter?

§ 870.2700 Oximeter. (a) Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.

What is a hospital grade pulse oximeter?

Pulse oximeters can measure blood oxygen saturation levels by sending light through the skin painlessly. Pulse oximeters have been used in hospitals and doctors' offices for decades. The small, painless devices measure blood oxygen saturation, which helps doctors decide how to treat patients.

For pdfFiller’s FAQs

What is APO-8284 Fingertip Pulse Oximeter FDA 510(k) Files?

APO-8284 Fingertip Pulse Oximeter FDA 510(k) Files are submissions made to the FDA to demonstrate that the fingertip pulse oximeter is safe and effective for its intended use, allowing it to be marketed in the United States.

Who is required to file APO-8284 Fingertip Pulse Oximeter FDA 510(k) Files?

Manufacturers or importers of the APO-8284 Fingertip Pulse Oximeter are required to file the FDA 510(k) Files to obtain clearance to market the device.

How to fill out APO-8284 Fingertip Pulse Oximeter FDA 510(k) Files?

To fill out the APO-8284 Fingertip Pulse Oximeter FDA 510(k) Files, manufacturers need to complete the 510(k) application form, provide device descriptions, submit performance testing data, and include labeling information that adheres to FDA guidelines.

What is the purpose of APO-8284 Fingertip Pulse Oximeter FDA 510(k) Files?

The purpose of the APO-8284 Fingertip Pulse Oximeter FDA 510(k) Files is to provide evidence to the FDA that the device is as safe and effective as a legally marketed predicate device, facilitating its approval for commercial sale.

What information must be reported on APO-8284 Fingertip Pulse Oximeter FDA 510(k) Files?

Information that must be reported includes device identification, intended use, description of the device, indications for use, safety and effectiveness data, and comparisons to predicate devices.