FDA 510(k) Application Details - K151024

Device Classification Name Oximeter

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510(K) Number K151024
Device Name Oximeter
Applicant TAIDOC TECHNOLOGY CORPORATION
6F, NO. 127, WUGONG 2ND RD., WUGU DISTRICT
NEW TAIPEI CITY 24888 TW
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Contact C. W. CHEN
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 04/16/2015
Decision Date 03/02/2016
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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