FDA 510(k) Application Details - K951998

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K951998
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant DIASONICS ULTRASOUND
2860 DELA CRUZ BLVD.
SANTA CLARA, CA 95050 US
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Contact GREGORY S LIN
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 04/28/1995
Decision Date 03/27/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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