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FDA 510(k), K062049, EVIS EXERA II 180 SYSTEM
FDA 510(k), K062049, EVIS EXERA II 180 SYSTEM
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510(K) Number: K062049
Device Name: EVIS EXERA II 180 SYSTEM
Manufacturer: OLYMPUS MEDICAL SYSTEMS CORPORATION
Device Classification Name: Endoscope, Accessories, Narrow Band Spectrum
Regulation Number: 876.1500
Classification Product Code: NWB
Date Received: 07/20/2006
Decision Date: 09/22/2006
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: EVIS EXERA II 180 SYSTEM
Manufacturer: OLYMPUS MEDICAL SYSTEMS CORPORATION
Device Classification Name: Endoscope, Accessories, Narrow Band Spectrum
Regulation Number: 876.1500
Classification Product Code: NWB
Date Received: 07/20/2006
Decision Date: 09/22/2006
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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