FDA 510(k), K163069, OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
FDA 510(k), K163069, OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
510(K) Number: K163069
Device Name: OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
Manufacturer: OLYMPUS MEDICAL SYSTEMS CORP.
Device Classification Name: system, imaging, gastrointestinal, wireless, capsule
Regulation Number: 876.1300
Classification Product Code: NEZ
Date Received: 11/02/2016
Decision Date: 01/19/2017
Regulation Medical Specialty: Gastroenterology/Urology
Total pages: 2186
Fully redacted pages: 1191
Content pages: 995
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