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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K874695
Device Name HEALTHDYNE APNEA/HEART MONITOR, MODEL 900
Applicant
Healthdyne, Inc.
1850 Pkwy. Pl., 12th Floor
Marietta,  GA  30067
Applicant Contact TIM COWART
Correspondent
Healthdyne, Inc.
1850 Pkwy. Pl., 12th Floor
Marietta,  GA  30067
Correspondent Contact TIM COWART
Regulation Number870.2300
Classification Product Code
DRT  
Date Received11/16/1987
Decision Date 01/29/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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