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This document provides a summary of the 510(k) premarket notification submitted by Sonomed Inc. for the VuMax High Resolution Ultrasound System, intended for ophthalmic applications.
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How to fill out sonomed vumax 510k summary
How to fill out Sonomed VuMax 510(k) Summary
01
Gather all necessary information about the Sonomed VuMax device.
02
Identify the intended use and indications for the device.
03
Describe the device's technological characteristics.
04
Include a comparison to a predicate device to demonstrate substantial equivalence.
05
Summarize the results of any performance testing or clinical studies.
06
Provide labeling information, including instructions for use.
07
Compile all supporting documentation and data needed for submission.
08
Review the summary for accuracy and completeness before submission.
Who needs Sonomed VuMax 510(k) Summary?
01
Manufacturers of the Sonomed VuMax device seeking FDA approval.
02
Regulatory consultants assisting in the 510(k) submission process.
03
Healthcare providers and end-users who need to be informed about the device.
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What is Sonomed VuMax 510(k) Summary?
The Sonomed VuMax 510(k) Summary is a document submitted to the FDA that provides evidence that the Sonomed VuMax medical device is safe and effective for its intended use, and it is substantially equivalent to a legally marketed device.
Who is required to file Sonomed VuMax 510(k) Summary?
Manufacturers or sponsors of the Sonomed VuMax device are required to file the 510(k) Summary as part of the premarket notification process to demonstrate its safety and efficacy before marketing.
How to fill out Sonomed VuMax 510(k) Summary?
To fill out the Sonomed VuMax 510(k) Summary, manufacturers must provide specific information including details about the device, its intended use, comparisons with predicate devices, safety and performance data, and any labeling information.
What is the purpose of Sonomed VuMax 510(k) Summary?
The purpose of the Sonomed VuMax 510(k) Summary is to obtain FDA clearance for the medical device by demonstrating that it is safe and effective, and to provide transparency regarding the device's specifications and equivalences to existing products.
What information must be reported on Sonomed VuMax 510(k) Summary?
The information required in the Sonomed VuMax 510(k) Summary includes device identification, manufacturer's information, a description of the device and its intended use, comparisons with predicate devices, safety and efficacy data, and labeling information.
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