FDA 510(k) Application Details - K960602

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K960602
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 MICHELLE DR.
P.O. BOX 2068
TUSTIN, CA 92781-2068 US
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Contact STEVEN M KAY
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 01/16/1996
Decision Date 03/21/1996
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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