• FDA DYMISTA NDA 202236 approval records — 22 FDA documents, 848 pages
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FDA 510(k) K952882, PERSONAL TELEMEDICINE SYSTEM, by American Telecare, Inc.

FDA 510(k) K952882, PERSONAL TELEMEDICINE SYSTEM, by American Telecare, Inc.

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510(K) Number: K952882
Device Name: PERSONAL TELEMEDICINE SYSTEM
Manufacturer: American Telecare, Inc.
Device Classification Name: system, measurement, blood-pressure, non-invasive
Regulation Number: 870.1130
Classification Product Code: DXN
Date Received: 06/23/1995
Decision Date: 09/09/1996
Regulation Medical Specialty: Cardiovascular
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