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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
Applicant
Conmed Corporation
525 French Rd.
Utica,  NY  13502
Applicant Contact IRA DUESLER
Correspondent
Conmed Corporation
525 French Rd.
Utica,  NY  13502
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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