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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Strip, Temperature, Forehead, Liquid Crystal
510(k) Number K760683
Device Name ALARM, THERMAL, THERM-ALERT
Applicant
RESPIRATORY CARE, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
RESPIRATORY CARE, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.2200
Classification Product Code
KPD  
Date Received09/20/1976
Decision Date 09/27/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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