H-500 ALLIANCE OXYGEN CONCENTRATOR

Generator, Oxygen, Portable

HEALTHDYNE, INC.

The following data is part of a premarket notification filed by Healthdyne, Inc. with the FDA for H-500 Alliance Oxygen Concentrator.

Pre-market Notification Details

Device IDK942357
510k NumberK942357
Device Name:H-500 ALLIANCE OXYGEN CONCENTRATOR
ClassificationGenerator, Oxygen, Portable
Applicant HEALTHDYNE, INC. 1255 KENNESTONE CIRCLE Marietta,  GA  30066
ContactTimothy Y Cowart
CorrespondentTimothy Y Cowart
HEALTHDYNE, INC. 1255 KENNESTONE CIRCLE Marietta,  GA  30066
Product CodeCAW  
CFR Regulation Number868.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-05-17
Decision Date1994-05-27

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