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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oximeter
510(k) Number K061112
Device Name CONMED PRO2 PULSE REFLECTANCE OXIMETER, MODEL PRO-M
Applicant
CONMED CORPORATION
525 FRENCH ROAD
UTICA,  NY  13502
Applicant Contact IRA DUESLER
Correspondent
CONMED CORPORATION
525 FRENCH ROAD
UTICA,  NY  13502
Correspondent Contact IRA DUESLER
Regulation Number870.2700
Classification Product Code
DQA  
Date Received04/21/2006
Decision Date 05/22/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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