FDA 510(k) Application Details - K953752

Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic

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510(K) Number K953752
Device Name System, Imaging, Pulsed Echo, Ultrasonic
Applicant GENERAL ELECTRIC CO.
P0 BOX 414
MILWAUKEE, WI US
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Contact ALLEN SCHUH
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Regulation Number 892.1560

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Classification Product Code IYO
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Date Received 08/10/1995
Decision Date 03/15/1996
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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