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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K922937
Device Name FLEXIBLE FIBER OPTIC ENDOSCOPE
Applicant
Optimed Technologies, Inc.
2440 N. Glassell St.
Suite J
Orange,  CA  92665
Applicant Contact RONALD J EHMSEN
Correspondent
Optimed Technologies, Inc.
2440 N. Glassell St.
Suite J
Orange,  CA  92665
Correspondent Contact RONALD J EHMSEN
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received06/18/1992
Decision Date 09/14/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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