FDA 510(k) Application Details - K060649

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K060649
Device Name Thermometer, Electronic, Clinical
Applicant TYCO HEALTHCARE GROUP, LP
15 HAMPSHIRE ST.
MANSFIELD, MA 02048 US
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Contact KEITH MARTIN
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 03/13/2006
Decision Date 05/22/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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