BP8800T/8000IR/8300G NON-INVASIVE BLOOD PRES. SYST

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 Bp8800t/8000ir/8300g Non-invasive Blood Pres. Syst.

Pre-market Notification Details

Device IDK921048
510k NumberK921048
Device Name:BP8800T/8000IR/8300G NON-INVASIVE BLOOD PRES. SYST
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant COLIN MEDICAL INSTRUMENTS CORP. 5850 FARINON DR. San Antonio,  TX  78249
ContactAlan P Schwartz
CorrespondentAlan P Schwartz
COLIN MEDICAL INSTRUMENTS CORP. 5850 FARINON DR. San Antonio,  TX  78249
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-03-04
Decision Date1993-07-01

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