IN-LINE OXYGEN MONITORING SYSTEM

Monitor, Blood-gas, On-line, Cardiopulmonary Bypass

G.D. SEARLE AND CO.

The following data is part of a premarket notification filed by G.d. Searle And Co. with the FDA for In-line Oxygen Monitoring System.

Pre-market Notification Details

Device IDK821159
510k NumberK821159
Device Name:IN-LINE OXYGEN MONITORING SYSTEM
ClassificationMonitor, Blood-gas, On-line, Cardiopulmonary Bypass
Applicant G.D. SEARLE AND CO. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeDRY  
CFR Regulation Number870.4330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-04-22
Decision Date1982-05-25

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