FDA 510(k), K093395, OLYMPUS GF TYPE UC180, OLYMPUS GF TYPE UCT180 EVIS EXERA II ULATRASOUND GASTROVIDEOSCOPE
FDA 510(k), K093395, OLYMPUS GF TYPE UC180, OLYMPUS GF TYPE UCT180 EVIS EXERA II ULATRASOUND GASTROVIDEOSCOPE
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510(K) Number: K093395
Device Name: OLYMPUS GF TYPE UC180, OLYMPUS GF TYPE UCT180 EVIS EXERA II ULATRASOUND GASTROVIDEOSCOPE
Manufacturer: OLYMPUS MEDICAL SYSTEMS CORPORATION
Device Classification Name: System, Imaging, Pulsed Doppler, Ultrasonic
Regulation Number: 892.1550
Classification Product Code: IYN
Date Received: 10/30/2009
Decision Date: 06/17/2010
Regulation Medical Specialty: Radiology
863 pages (273 of 1,136 pages are fully redacted)