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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thermometer, Electronic, Clinical
510(k) Number K920469
Device Name MYOCARDINAL TEMPERATURE SENSOR WITH TYPE 400 SERIE
Applicant
RESPIRATORY SUPPORT PRODUCTS, INC.
2552 MCGAW AVE.
IRVINE,  CA  92614
Applicant Contact KERRY TOMIC
Correspondent
RESPIRATORY SUPPORT PRODUCTS, INC.
2552 MCGAW AVE.
IRVINE,  CA  92614
Correspondent Contact KERRY TOMIC
Regulation Number880.2910
Classification Product Code
FLL  
Date Received01/27/1992
Decision Date 09/11/1992
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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