ELECTRONIC APGAR TIMER

Timer, Apgar

PT&E

The following data is part of a premarket notification filed by Pt&e with the FDA for Electronic Apgar Timer.

Pre-market Notification Details

Device IDK811424
510k NumberK811424
Device Name:ELECTRONIC APGAR TIMER
ClassificationTimer, Apgar
Applicant PT&E 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeLHB  
CFR Regulation Number880.2930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-05-22
Decision Date1981-07-09

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