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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 K022542
Device Name PHILIPS BABY THERMOMETER SET (SBC SC530)
Applicant
Philips Consumer Electronics
One Philips Dr.
Knoxville,  TN  37914
Applicant Contact BOB POOLER
Correspondent
Philips Consumer Electronics
One Philips Dr.
Knoxville,  TN  37914
Correspondent Contact BOB POOLER
Regulation Number880.2910
Classification Product Code
FLL  
Date Received08/01/2002
Decision Date 08/20/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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