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FDA 510(k), K192662, CapsoCam Plus (SV-3) Capsule Endoscopy System
FDA 510(k), K192662, CapsoCam Plus (SV-3) Capsule Endoscopy System
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510(K) Number: K192662
Device Name: CapsoCam Plus (SV-3) Capsule Endoscopy System
Manufacturer: CapsoVision, Inc.
Device Classification Name: System, Imaging, Gastrointestinal, Wireless, Capsule
Regulation Number: 876.1300
Classification Product Code: NEZ
Date Received: 09/25/2019
Decision Date: 02/14/2020
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: CapsoCam Plus (SV-3) Capsule Endoscopy System
Manufacturer: CapsoVision, Inc.
Device Classification Name: System, Imaging, Gastrointestinal, Wireless, Capsule
Regulation Number: 876.1300
Classification Product Code: NEZ
Date Received: 09/25/2019
Decision Date: 02/14/2020
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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