FDA 510(k) Application Details - K013273

Device Classification Name Oximeter

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510(K) Number K013273
Device Name Oximeter
Applicant FUKUDA DENSHI USA, INC.
17725 N.E. 65TH ST., BLDG. C
REDMOND, WA 98052-4911 US
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Contact LARRY WALKER
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 10/01/2001
Decision Date 12/20/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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