FDA 510(k), K181240, Rhino-Laryngo Fiberscope Olympus ENF-GP2
FDA 510(k), K181240, Rhino-Laryngo Fiberscope Olympus ENF-GP2
510(K) Number: K181240
Device Name: Rhino-Laryngo Fiberscope Olympus ENF-GP2
Manufacturer: Olympus Medical Systems Corp.
Device Classification Name: Nasopharyngoscope (Flexible Or Rigid)
Regulation Number: 874.4760
Classification Product Code: EOB
Date Received: 05/10/2018
Decision Date: 10/04/2018
Regulation Medical Specialty: Ear Nose & Throat
430 pages (1,273 of 1,703 original pages are fully redacted)
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