BP-308 MARK II

Electrocardiograph

COLIN MEDICAL INSTRUMENTS CORP.

The following data is part of a premarket notification filed by Colin Medical Instruments Corp. with the FDA for Bp-308 Mark Ii.

Pre-market Notification Details

Device IDK884896
510k NumberK884896
Device Name:BP-308 MARK II
ClassificationElectrocardiograph
Applicant COLIN MEDICAL INSTRUMENTS CORP. 107G CORPORATE BLVD. South Plainfield,  NJ  07080
ContactAlan P Schwartz
CorrespondentAlan P Schwartz
COLIN MEDICAL INSTRUMENTS CORP. 107G CORPORATE BLVD. South Plainfield,  NJ  07080
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-11-22
Decision Date1989-02-23

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