FLEXIBLE FIBER OPTIC ENDOSCOPE

Bronchoscope (flexible Or Rigid)

OPTIMED TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Optimed Technologies, Inc. with the FDA for Flexible Fiber Optic Endoscope.

Pre-market Notification Details

Device IDK922937
510k NumberK922937
Device Name:FLEXIBLE FIBER OPTIC ENDOSCOPE
ClassificationBronchoscope (flexible Or Rigid)
Applicant OPTIMED TECHNOLOGIES, INC. 2440 N. GLASSELL ST. SUITE J Orange,  CA  92665
ContactRonald J Ehmsen
CorrespondentRonald J Ehmsen
OPTIMED TECHNOLOGIES, INC. 2440 N. GLASSELL ST. SUITE J Orange,  CA  92665
Product CodeEOQ  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-06-18
Decision Date1992-09-14

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