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Manufacturer Disclosure Statement for Medical Device Security MDS2 Device Category: 16512Manufacturer: Care stream Health, Inc. Document ID: 7H4185Device Model: PoC 360,260,140,120Software Revision
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This category may also be required by regulatory authorities or compliance standards to ensure proper documentation and tracking of devices.
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What is device category 16512?
Device category 16512 includes all medical devices used for cardiology purposes.
Who is required to file device category 16512?
Manufacturers and distributors of medical devices falling under category 16512 are required to file.
How to fill out device category 16512?
Device category 16512 can be filled out by providing detailed information about the device, its purpose, intended use, and any specific requirements.
What is the purpose of device category 16512?
The purpose of device category 16512 is to track and monitor cardiology medical devices for regulatory purposes.
What information must be reported on device category 16512?
Information such as device specifications, intended use, manufacturing details, and any adverse events related to the device must be reported on device category 16512.
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