FDA 510(k) Application Details - K191207

Device Classification Name Oximeter

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510(K) Number K191207
Device Name Oximeter
Applicant Taiwan Aulisa Medical Devices Technologies, Inc.
Rm. 1052, Bldg. H, 10F., No.3-2, YuanQu St., Nangang Dist.
Taipei City 115 TW
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Contact Paul Liu
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 05/06/2019
Decision Date 06/25/2019
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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