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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
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