MODEL PB3300 INTRA-ARTER BLOOD GAS MONIT SYS, MODI

Analyzer, Ion, Hydrogen-ion (ph), Blood-phase, Indwelling

PURITAN BENNETT CORP.

The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Model Pb3300 Intra-arter Blood Gas Monit Sys, Modi.

Pre-market Notification Details

Device IDK931112
510k NumberK931112
Device Name:MODEL PB3300 INTRA-ARTER BLOOD GAS MONIT SYS, MODI
ClassificationAnalyzer, Ion, Hydrogen-ion (ph), Blood-phase, Indwelling
Applicant PURITAN BENNETT CORP. 6088 CORTE DEL CEDRO Carlsbad,  CA  92009
ContactWilliam M Townsend
CorrespondentWilliam M Townsend
PURITAN BENNETT CORP. 6088 CORTE DEL CEDRO Carlsbad,  CA  92009
Product CodeCBZ  
CFR Regulation Number868.1170 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-03-04
Decision Date1993-06-01

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