FDA 510(k), K151086, ManoScan System
FDA 510(k), K151086, ManoScan System
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510(K) Number: K151086
Device Name: ManoScan System
Manufacturer: GIVEN IMAGING LTD.
Device Classification Name: System, Gastrointestinal Motility (Electrical)
Regulation Number: 876.1725
Classification Product Code: FFX
Date Received: 04/22/2015
Decision Date: 04/28/2016
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: ManoScan System
Manufacturer: GIVEN IMAGING LTD.
Device Classification Name: System, Gastrointestinal Motility (Electrical)
Regulation Number: 876.1725
Classification Product Code: FFX
Date Received: 04/22/2015
Decision Date: 04/28/2016
Regulation Medical Specialty: Gastroenterology/Urology
- 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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