PULSEMATE BX-5

Oximeter

COLIN MEDICAL INSTRUMENTS CORP.

The following data is part of a premarket notification filed by Colin Medical Instruments Corp. with the FDA for Pulsemate Bx-5.

Pre-market Notification Details

Device IDK874692
510k NumberK874692
Device Name:PULSEMATE BX-5
ClassificationOximeter
Applicant COLIN MEDICAL INSTRUMENTS CORP. 1330 CONNECTICUT AVENUE, N.W. Washington,  DC  20036
ContactEdward M Lebow
CorrespondentEdward M Lebow
COLIN MEDICAL INSTRUMENTS CORP. 1330 CONNECTICUT AVENUE, N.W. Washington,  DC  20036
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-11-16
Decision Date1988-02-02

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