FDA 510(k) Application Details - K961357

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K961357
Device Name Thermometer, Electronic, Clinical
Applicant INTELLIGENT PRODUCT LIMITED CO.
463 N. OREM BLVD.
OREM, UT 84057 US
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Contact MATTHEW KHO
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 04/08/1996
Decision Date 08/16/1996
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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