FDA 510(k) Application Details - K050230

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K050230
Device Name Thermometer, Electronic, Clinical
Applicant CARDINAL HEALTH, ALARIS PRODUCTS
10221 WATERIDGE CIRCLE
SAN DIEGO, CA 92121-2772 US
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Contact STACY L LEWIS
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 02/01/2005
Decision Date 02/16/2005
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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