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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, breathing frequency
510(k) Number K903287
Device Name MODEL 900S APNEA/HEART MONITOR
Applicant
HEALTHDYNE, INC.
1850 PARKWAY PLACE, 12TH FLOOR
MARIETTA,  GA  30067 -8274
Applicant Contact TIMOTHY Y COWART
Correspondent
HEALTHDYNE, INC.
1850 PARKWAY PLACE, 12TH FLOOR
MARIETTA,  GA  30067 -8274
Correspondent Contact TIMOTHY Y COWART
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received07/11/1990
Decision Date 08/17/1990
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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