FDA 510(k) Application Details - K941593

Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic

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510(K) Number K941593
Device Name System, Imaging, Pulsed Echo, Ultrasonic
Applicant TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 MICHELLE DR.
P.O. BOX 2068
TUSTIN, CA 92781-2068 US
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Contact JAVAD SEYEDZADEH
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Regulation Number 892.1560

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Classification Product Code IYO
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Date Received 04/01/1994
Decision Date 05/17/1996
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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