FDA 510(k) Application Details - K962796

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K962796
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant MEDASONICS, INC.
9712 S. ALTAMONT DR.
SANDY, UT 84092 US
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Contact WILLIAM E MCKAY
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 07/18/1996
Decision Date 01/21/1997
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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