ME20 TRACERITE CLEAR VENT TAPE, ME30 TRACERITE NON

Electrode, Electrocardiograph

BRISTOL MEDICAL ELECTRONICS CORP.

The following data is part of a premarket notification filed by Bristol Medical Electronics Corp. with the FDA for Me20 Tracerite Clear Vent Tape, Me30 Tracerite Non.

Pre-market Notification Details

Device IDK844856
510k NumberK844856
Device Name:ME20 TRACERITE CLEAR VENT TAPE, ME30 TRACERITE NON
ClassificationElectrode, Electrocardiograph
Applicant BRISTOL MEDICAL ELECTRONICS CORP. 171C FORBES BLVD. P.O. BOX 809 Mansfield,  MA  02048
ContactDonald C Epstein
CorrespondentDonald C Epstein
BRISTOL MEDICAL ELECTRONICS CORP. 171C FORBES BLVD. P.O. BOX 809 Mansfield,  MA  02048
Product CodeDRX  
CFR Regulation Number870.2360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-12-14
Decision Date1985-02-20

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