ELECTRO BLUE ECG ELECT. FOAM, SILVER/SILVER CHLO.

Electrode, Electrocardiograph

LABELTAPE MEDITECT, INC.

The following data is part of a premarket notification filed by Labeltape Meditect, Inc. with the FDA for Electro Blue Ecg Elect. Foam, Silver/silver Chlo..

Pre-market Notification Details

Device IDK894991
510k NumberK894991
Device Name:ELECTRO BLUE ECG ELECT. FOAM, SILVER/SILVER CHLO.
ClassificationElectrode, Electrocardiograph
Applicant LABELTAPE MEDITECT, INC. 4275 AIRWEST DR., S.E. P.O. BOX 8823 Grand Rapids,  MI  49508
ContactLora Jones
CorrespondentLora Jones
LABELTAPE MEDITECT, INC. 4275 AIRWEST DR., S.E. P.O. BOX 8823 Grand Rapids,  MI  49508
Product CodeDRX  
CFR Regulation Number870.2360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-08-08
Decision Date1989-10-26

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