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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 K843546
Device Name INFANT MONITOR 16900
Applicant
Healthdyne, Inc.
2253 Northwest Pkwy.
Marietta,  GA  30067
Applicant Contact TIM COWART
Correspondent
Healthdyne, Inc.
2253 Northwest Pkwy.
Marietta,  GA  30067
Correspondent Contact TIM COWART
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received09/10/1984
Decision Date 10/10/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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