FDA 510(k) Application Details - K102023

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K102023
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI
7263 CRONIN CIRCLE
DUBLIN, CA 94568 US
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Contact BOB LEIKER
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 07/19/2010
Decision Date 10/19/2010
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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