FDA 510(k) Application Details - K974544

Device Classification Name Transducer, Ultrasonic, Diagnostic

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510(K) Number K974544
Device Name Transducer, Ultrasonic, Diagnostic
Applicant ALOKA CO., LTD.
10 FAIRFIELD BLVD.
WALLINGFORD, CT 06492 US
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Contact PAUL D SMOLENSKI
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Regulation Number 892.1570

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Classification Product Code ITX
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Date Received 12/04/1997
Decision Date 03/18/1998
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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