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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 K780260
Device Name TEMP. SENSOR W/22MM FITTINGS
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
1875 Eye St. NW Suite 625
Washington,  DC  20006
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
1875 Eye St. NW Suite 625
Washington,  DC  20006
Regulation Number880.2200
Classification Product Code
KPD  
Date Received02/15/1978
Decision Date 03/14/1978
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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