PRESS-MATE BP8800MS AUTOMATIC NON-INVASIVE BLOOD PRESSURE SYSTEM

System, Measurement, Blood-pressure, Non-invasive

COLIN MEDICAL INSTRUMENTS CORP.

The following data is part of a premarket notification filed by Colin Medical Instruments Corp. with the FDA for Press-mate Bp8800ms Automatic Non-invasive Blood Pressure System.

Pre-market Notification Details

Device IDK942871
510k NumberK942871
Device Name:PRESS-MATE BP8800MS AUTOMATIC NON-INVASIVE BLOOD PRESSURE SYSTEM
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant COLIN MEDICAL INSTRUMENTS CORP. 55 NORTHERN BLVD. SUITE 410 Great Neck,  NY  11021
ContactSusan D Goldstein-falk
CorrespondentSusan D Goldstein-falk
COLIN MEDICAL INSTRUMENTS CORP. 55 NORTHERN BLVD. SUITE 410 Great Neck,  NY  11021
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-06-17
Decision Date1994-10-17

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