FLOW SPIROMETER

Meter, Peak Flow, Spirometry

HEALTHDYNE, INC.

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

Pre-market Notification Details

Device IDK934502
510k NumberK934502
Device Name:FLOW SPIROMETER
ClassificationMeter, Peak Flow, Spirometry
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 CodeBZH  
CFR Regulation Number868.1860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-09-14
Decision Date1994-04-04

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