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FDA 510(k), K150095, ReDs Wearable System
FDA 510(k), K150095, ReDs Wearable System
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510(K) Number: K150095
Device Name: ReDs Wearable System
Manufacturer: SENSIBLE MEDICAL INNOVATIONS LTD.
Device Classification Name: Plethysmograph, Impedance
Regulation Number: 870.2770
Classification Product Code: DSB
Date Received: 01/16/2015
Decision Date: 08/06/2015
Regulation Medical Specialty: Cardiovascular
Device Name: ReDs Wearable System
Manufacturer: SENSIBLE MEDICAL INNOVATIONS LTD.
Device Classification Name: Plethysmograph, Impedance
Regulation Number: 870.2770
Classification Product Code: DSB
Date Received: 01/16/2015
Decision Date: 08/06/2015
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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