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FDA 510(k), K161431, SimplECG
FDA 510(k), K161431, SimplECG
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510(K) Number: K161431
Device Name: SimplECG
Manufacturer: Nanowear Inc.
Device Classification Name: transmitters and receivers, electrocardiograph, telephone
Regulation Number: 870.2920
Classification Product Code: DXH
Date Received: 05/24/2016
Decision Date: 11/30/2016
Regulation Medical Specialty: Cardiovascular
Device Name: SimplECG
Manufacturer: Nanowear Inc.
Device Classification Name: transmitters and receivers, electrocardiograph, telephone
Regulation Number: 870.2920
Classification Product Code: DXH
Date Received: 05/24/2016
Decision Date: 11/30/2016
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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