FDA 510(k) Application Details - K040652

Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic

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510(K) Number K040652
Device Name System, Imaging, Pulsed Echo, Ultrasonic
Applicant MOBILSONIC, INC.
560 PARROTT STREET
SAN JOSE, CA 95112 US
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Contact BAO LE
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Regulation Number 892.1560

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Classification Product Code IYO
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Date Received 03/11/2004
Decision Date 05/17/2004
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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