FDA 510(k) Application Details - K010502

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K010502
Device Name Thermometer, Electronic, Clinical
Applicant SAAT LTD.
1468 HARWELL AVE.
CROFTON,, MD 21114 US
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Contact E. J SMITH
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 02/21/2001
Decision Date 02/27/2001
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 Y
Expedited Review



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