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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
510(k) Number K931112
Device Name MODEL PB3300 INTRA-ARTER BLOOD GAS MONIT SYS, MODI
Applicant
Puritan Bennett Corp.
6088 Corte Del Cedro
Carlsbad,  CA  92009
Applicant Contact WILLIAM M TOWNSEND
Correspondent
Puritan Bennett Corp.
6088 Corte Del Cedro
Carlsbad,  CA  92009
Correspondent Contact WILLIAM M TOWNSEND
Regulation Number868.1170
Classification Product Code
CBZ  
Date Received03/04/1993
Decision Date 06/01/1993
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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