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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 K833755
Device Name ELECTRONIC DIGITAL FEVER THERMOMETER
Applicant
North American Philips Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
North American Philips Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.2910
Classification Product Code
FLL  
Date Received10/26/1983
Decision Date 01/30/1984
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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