HEALTHDYNE MODEL 16900 INFANT MONITOR

Monitor, Breathing Frequency

HEALTHDYNE, INC.

The following data is part of a premarket notification filed by Healthdyne, Inc. with the FDA for Healthdyne Model 16900 Infant Monitor.

Pre-market Notification Details

Device IDK821731
510k NumberK821731
Device Name:HEALTHDYNE MODEL 16900 INFANT MONITOR
ClassificationMonitor, Breathing Frequency
Applicant HEALTHDYNE, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeBZQ  
CFR Regulation Number868.2375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-06-01
Decision Date1982-07-13

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