FDA 510(k) Application Details - K991805

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K991805
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant ACUSON CORP.
1220 CHARLESTON RD.
MOUNTAIN VIEW, CA 94039-7393 US
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Contact WILLIAM WELCH
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 05/26/1999
Decision Date 08/02/1999
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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