FDA 510(k) Application Details - K955846

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K955846
Device Name Thermometer, Electronic, Clinical
Applicant Y
10300 CAMPUS POINT DR.
SAN DIEGO, CA 92121-1579 US
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Contact JENNIFER S HANKARD
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 12/26/1995
Decision Date 10/01/1996
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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