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FDA 510(k), K203192, NaviCam Xpress Stomach System
FDA 510(k), K203192, NaviCam Xpress Stomach System
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$149.00 USD
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510(K) Number: K203192
Device Name: NaviCam Xpress Stomach System
Manufacturer: AnX Robotica Corp
Device Classification Name: Magnetically Maneuvered Capsule Endoscopy System
Regulation Number: 876.1310
Classification Product Code: QKZ
Date Received: 10/28/2020
Decision Date: 05/04/2021
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: NaviCam Xpress Stomach System
Manufacturer: AnX Robotica Corp
Device Classification Name: Magnetically Maneuvered Capsule Endoscopy System
Regulation Number: 876.1310
Classification Product Code: QKZ
Date Received: 10/28/2020
Decision Date: 05/04/2021
Regulation Medical Specialty: Gastroenterology/Urology
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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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