FDA 510(k) Application Details - K051736

Device Classification Name Oximeter

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510(K) Number K051736
Device Name Oximeter
Applicant SHUNSUKE NAKANISHI
2600 MISSION STREET, SUITE 100
SAN MARIN0, CA 91108 US
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Contact YINGCHAO XIAO
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 06/28/2005
Decision Date 12/02/2005
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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