FDA 510(k) Application Details - K934915

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K934915
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant ACUSON CORP.
1220 CHARLESTON RD.
MOUNTAIN VIEW, CA US
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Contact STEPHEN T JOHNSON
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 10/15/1993
Decision Date 10/21/1994
Decision SE - Substantially Equivalent
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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