FDA 510(k) Application Details - K954220

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K954220
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant HITACHI MEDICAL CORP. OF AMERICA
660 WHITE PLAINS RD.
TARRYTOWN, NY 10591 US
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Contact CHARLES F HOTTINGER
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 09/11/1995
Decision Date 05/07/1997
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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