FDA 510(k) Application Details - K172895

Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive

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510(K) Number K172895
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant Ageless Health Industrial Co., Ltd
3/F, A1 Bldg, Dongshen Sima Industrial Area,
No.33 Shenbei Road, Sima Village,
Dongguan 523000 CN
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Contact Victor Wan
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 09/22/2017
Decision Date 06/18/2018
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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