STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(597 ADHE)

Transmitters And Receivers, Electrocardiograph, Telephone

LABELTAPE MEDITECT, INC.

The following data is part of a premarket notification filed by Labeltape Meditect, Inc. with the FDA for Stand. Clear Vinyl Disposable Ecg Elect.(597 Adhe).

Pre-market Notification Details

Device IDK872869
510k NumberK872869
Device Name:STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(597 ADHE)
ClassificationTransmitters And Receivers, Electrocardiograph, Telephone
Applicant LABELTAPE MEDITECT, INC. 4275 AIRWEST DR., S.E. P.O. BOX 8823 Grand Rapids,  MI  49508
ContactMichael S Bartlett
CorrespondentMichael S Bartlett
LABELTAPE MEDITECT, INC. 4275 AIRWEST DR., S.E. P.O. BOX 8823 Grand Rapids,  MI  49508
Product CodeDXH  
CFR Regulation Number870.2920 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-07-21
Decision Date1987-11-04

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