INFANT MONITOR

Monitor, Breathing Frequency

HEALTHDYNE, INC.

The following data is part of a premarket notification filed by Healthdyne, Inc. with the FDA for Infant Monitor.

Pre-market Notification Details

Device IDK861484
510k NumberK861484
Device Name:INFANT MONITOR
ClassificationMonitor, Breathing Frequency
Applicant HEALTHDYNE, INC. 1850 PARKWAY PLACE, 12TH FLOOR Marietta,  GA  30067 -8274
ContactTim Cowart
CorrespondentTim Cowart
HEALTHDYNE, INC. 1850 PARKWAY PLACE, 12TH FLOOR Marietta,  GA  30067 -8274
Product CodeBZQ  
CFR Regulation Number868.2375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-04-22
Decision Date1986-05-21

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