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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 K990168
Device Name MICROLIFE IT2CA1
Applicant
Microlife Systems AG
1330 W. Citizens Blvd.,
Suite 402-404
Leesburg,  FL  34748
Applicant Contact SCOT J DUBE
Correspondent
Microlife Systems AG
1330 W. Citizens Blvd.,
Suite 402-404
Leesburg,  FL  34748
Correspondent Contact SCOT J DUBE
Regulation Number880.2910
Classification Product Code
FLL  
Date Received01/19/1999
Decision Date 02/25/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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