FDA 510(k) Application Details - K072108

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K072108
Device Name Thermometer, Electronic, Clinical
Applicant TECNIMED S.R.L.
55 Northern Blvd.
Suite 200
Great Neck, NY 11021 US
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Contact MARIA F GRIFFIN
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 08/01/2007
Decision Date 08/31/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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