BIOCHEM 3100 OXIMETER

Catheter, Intravascular, Diagnostic

BIOCHEM INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Biochem International, Inc. with the FDA for Biochem 3100 Oximeter.

Pre-market Notification Details

Device IDK893877
510k NumberK893877
Device Name:BIOCHEM 3100 OXIMETER
ClassificationCatheter, Intravascular, Diagnostic
Applicant BIOCHEM INTERNATIONAL, INC. W238 N1650 ROCKWOOD DR. Waukesha,  WI  53186
ContactKeith Harper
CorrespondentKeith Harper
BIOCHEM INTERNATIONAL, INC. W238 N1650 ROCKWOOD DR. Waukesha,  WI  53186
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-05-26
Decision Date1989-12-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
35019517053696 K893877 000
35019517042584 K893877 000
35019517042577 K893877 000
35019517042560 K893877 000
15019517042559 K893877 000
15019517042542 K893877 000

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