BIOCHEM 9100 MULTIGAS MONITOR

Analyzer, Gas, Carbon-dioxide, Gaseous-phase

BIOCHEM INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Biochem International, Inc. with the FDA for Biochem 9100 Multigas Monitor.

Pre-market Notification Details

Device IDK901861
510k NumberK901861
Device Name:BIOCHEM 9100 MULTIGAS MONITOR
ClassificationAnalyzer, Gas, Carbon-dioxide, Gaseous-phase
Applicant BIOCHEM INTERNATIONAL, INC. W238 N1650 ROCKWOOD DR. Waukesha,  WI  53186
ContactDavid A Uhen
CorrespondentDavid A Uhen
BIOCHEM INTERNATIONAL, INC. W238 N1650 ROCKWOOD DR. Waukesha,  WI  53186
Product CodeCCK  
CFR Regulation Number868.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-04-25
Decision Date1990-07-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15019517042535 K901861 000
15019517042528 K901861 000

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