CARD GUARD-3000 ECG TELEPHONE ADAPTER

Transmitters And Receivers, Electrocardiograph, Telephone

MEDTECH INDUSTRIES, INC.

The following data is part of a premarket notification filed by Medtech Industries, Inc. with the FDA for Card Guard-3000 Ecg Telephone Adapter.

Pre-market Notification Details

Device IDK910450
510k NumberK910450
Device Name:CARD GUARD-3000 ECG TELEPHONE ADAPTER
ClassificationTransmitters And Receivers, Electrocardiograph, Telephone
Applicant MEDTECH INDUSTRIES, INC. C/O HOGAN & HARTSON 555 THIRTEENTH STREET, N.W. Washington,  DC  20004
ContactJonathan S Kahan
CorrespondentJonathan S Kahan
MEDTECH INDUSTRIES, INC. C/O HOGAN & HARTSON 555 THIRTEENTH STREET, N.W. Washington,  DC  20004
Product CodeDXH  
CFR Regulation Number870.2920 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-02-01
Decision Date1991-05-07

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