EAR ELECTRODE-ADULT & PEDIATRIC

Electrode, Cutaneous

LIFE-TECH INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Life-tech Instruments, Inc. with the FDA for Ear Electrode-adult & Pediatric.

Pre-market Notification Details

Device IDK780537
510k NumberK780537
Device Name:EAR ELECTRODE-ADULT & PEDIATRIC
ClassificationElectrode, Cutaneous
Applicant LIFE-TECH INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGXY  
CFR Regulation Number882.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-04-03
Decision Date1978-06-02

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