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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name attachment, breathing, positive end expiratory pressure
510(k) Number K881833
Device Name NASAL CPAP SYSTEM
Applicant
HEALTHDYNE, INC.
1850 PARKWAY PLACE, 12TH FLOOR
MARIETTA,  GA  30067 -8274
Applicant Contact TIM COWART
Correspondent
HEALTHDYNE, INC.
1850 PARKWAY PLACE, 12TH FLOOR
MARIETTA,  GA  30067 -8274
Correspondent Contact TIM COWART
Regulation Number868.5965
Classification Product Code
BYE  
Date Received04/29/1988
Decision Date 06/24/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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