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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 K935280
Device Name MEMOTHERM 10 BABY THERMOMETER
Applicant
International Regulatory Consultants
Pob 1310
Efrat, Israel,  IL 90962
Applicant Contact ELI M ORBACH
Correspondent
International Regulatory Consultants
Pob 1310
Efrat, Israel,  IL 90962
Correspondent Contact ELI M ORBACH
Regulation Number880.2910
Classification Product Code
FLL  
Date Received11/03/1993
Decision Date 10/19/1994
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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