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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K925792
Device Name EXAC-TEMP & CLINI-TEMP TYMPANIC & MYOCARDIAL PROBE
Applicant
Deroyal Industries, Inc.
200 Debusk Ln.
Powell,  TN  37849
Applicant Contact DEBRA F MANNING
Correspondent
Deroyal Industries, Inc.
200 Debusk Ln.
Powell,  TN  37849
Correspondent Contact DEBRA F MANNING
Regulation Number880.2910
Classification Product Code
FLL  
Date Received11/16/1992
Decision Date 04/08/1994
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
Recalls CDRH Recalls
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