FDA 510(k) Application Details - K180174

Device Classification Name Oximeter

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510(K) Number K180174
Device Name Oximeter
Applicant Belun Technology Company Limited
Rm531B, floor 5, Core Building 2, 1 Science Park West Avenue
HK Science Park
Sha Tin HK
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Contact Leung Lap Wai Lydia
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 01/22/2018
Decision Date 05/29/2018
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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