BIORE CP-100 CARDIOPULMONARY MONITOR

Calculator, Pulmonary Function Data

BICORE MONITORING SYSTEMS

The following data is part of a premarket notification filed by Bicore Monitoring Systems with the FDA for Biore Cp-100 Cardiopulmonary Monitor.

Pre-market Notification Details

Device IDK900696
510k NumberK900696
Device Name:BIORE CP-100 CARDIOPULMONARY MONITOR
ClassificationCalculator, Pulmonary Function Data
Applicant BICORE MONITORING SYSTEMS 2 FARADAY Irvine,  CA  92718
ContactDavid B Viele
CorrespondentDavid B Viele
BICORE MONITORING SYSTEMS 2 FARADAY Irvine,  CA  92718
Product CodeBZC  
CFR Regulation Number868.1880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-02-13
Decision Date1990-11-29

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