NDM INFANT ECG PACKPAD

Media, Electroconductive

NEW DIMENSIONS IN MEDICINE, INC.

The following data is part of a premarket notification filed by New Dimensions In Medicine, Inc. with the FDA for Ndm Infant Ecg Packpad.

Pre-market Notification Details

Device IDK780631
510k NumberK780631
Device Name:NDM INFANT ECG PACKPAD
ClassificationMedia, Electroconductive
Applicant NEW DIMENSIONS IN MEDICINE, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGYB  
CFR Regulation Number882.1275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-04-17
Decision Date1978-05-03

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