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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Oxygen, Gaseous-Phase
510(k) Number K922438
Device Name PRO2 OXYGEN ANALYZER
Applicant
Martech Medical Products, Inc.
43223 Business Park Dr.
Temecula,  CA  92590
Applicant Contact STEVEN F MERCEREAU
Correspondent
Martech Medical Products, Inc.
43223 Business Park Dr.
Temecula,  CA  92590
Correspondent Contact STEVEN F MERCEREAU
Regulation Number868.1720
Classification Product Code
CCL  
Date Received05/22/1992
Decision Date 03/05/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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