FDA 510(k) Application Details - K990168

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K990168
Device Name Thermometer, Electronic, Clinical
Applicant MICROLIFE SYSTEMS AG
1330 WEST CITIZENS BLVD.,
SUITE 402-404
LEESBURG, FL 34748 US
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Contact SCOT J DUBE
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 01/19/1999
Decision Date 02/25/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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