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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 K032831
Device Name PRO 2 MONITOR, PRO 2 SENSOR, PRO2 HOLDER, PRO2 NEONATE HOLDER, MODELS, PRO- 200, ANS-200, AHL-200, NHL-200
Original Applicant
CONMED CORPORATION
525 french road
utica,  NY  13502
Original Contact ira duesler
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/11/2003
Decision Date 08/31/2004
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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