FDA 510(k) Application Details - K211527

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K211527
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant Exo Imaging Inc.
3600 Bridge Parkway Suite 102
Redwood City, CA 94065 US
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Contact Antoanela Gomard
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 05/17/2021
Decision Date 08/20/2021
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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