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FDA 510(k), K170438, MiroCam Capsule Endoscope System
FDA 510(k), K170438, MiroCam Capsule Endoscope System
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510(K) Number: K170438
Device Name: MiroCam Capsule Endoscope System
Manufacturer: IntroMedic Co., Ltd.
Device Classification Name: system, imaging, gastrointestinal, wireless, capsule
Regulation Number: 876.1300
Classification Product Code: NEZ
Date Received: 02/13/2017
Decision Date: 01/30/2018
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: MiroCam Capsule Endoscope System
Manufacturer: IntroMedic Co., Ltd.
Device Classification Name: system, imaging, gastrointestinal, wireless, capsule
Regulation Number: 876.1300
Classification Product Code: NEZ
Date Received: 02/13/2017
Decision Date: 01/30/2018
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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