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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 K940686
Device Name ELECTRONIC THERMOMETERS
Applicant
American Diagnostic Corp.
93 A Otis St.
West Babylon,  NY  11704
Applicant Contact MARC BLITSTEIN
Correspondent
American Diagnostic Corp.
93 A Otis St.
West Babylon,  NY  11704
Correspondent Contact MARC BLITSTEIN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received02/16/1994
Decision Date 07/08/1994
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
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