FDA 510(k) Application Details - K213862

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K213862
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant Qingdao Hisense Medical Equipment Co., Ltd
No. 399 Songling Road, Laoshan District
Qingdao 266100 CN
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Contact Yalan Wu
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 12/10/2021
Decision Date 06/08/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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