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FDA 510(k), K162515, COSMED K5 Wearable Metabolic Technology
FDA 510(k), K162515, COSMED K5 Wearable Metabolic Technology
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510(K) Number: K162515
Device Name: COSMED K5 Wearable Metabolic Technology
Manufacturer: COSMED S.r.l.
Device Classification Name: calculator, pulmonary function data
Regulation Number: 868.1880
Classification Product Code: BZC
Date Received: 09/08/2016
Decision Date: 06/20/2017
Regulation Medical Specialty: Anesthesiology
Device Name: COSMED K5 Wearable Metabolic Technology
Manufacturer: COSMED S.r.l.
Device Classification Name: calculator, pulmonary function data
Regulation Number: 868.1880
Classification Product Code: BZC
Date Received: 09/08/2016
Decision Date: 06/20/2017
Regulation Medical Specialty: Anesthesiology
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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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