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FDA 510(k), K191272, Wearable Device, Wearable Package
FDA 510(k), K191272, Wearable Device, Wearable Package
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510(K) Number: K191272
Device Name: Wearable Device, Wearable Package
Manufacturer: Current Health Ltd.
Device Classification Name: System, Network And Communication, Physiological Monitors
Regulation Number: 870.2300
Classification Product Code: MSX
Date Received: 05/13/2019
Decision Date: 07/12/2019
Regulation Medical Specialty: Cardiovascular
Device Name: Wearable Device, Wearable Package
Manufacturer: Current Health Ltd.
Device Classification Name: System, Network And Communication, Physiological Monitors
Regulation Number: 870.2300
Classification Product Code: MSX
Date Received: 05/13/2019
Decision Date: 07/12/2019
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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