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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 K852954
Device Name B-D DIGITAL FEVER THERMOMETER
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
MACK CENTRE DR.
P.O.BOX 2224
PARAMUS,  NJ  07652
Applicant Contact RUSSELL J ARNSBERGE
Correspondent
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
MACK CENTRE DR.
P.O.BOX 2224
PARAMUS,  NJ  07652
Correspondent Contact RUSSELL J ARNSBERGE
Regulation Number880.2910
Classification Product Code
FLL  
Date Received07/11/1985
Decision Date 08/05/1985
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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