FDA 510(k) Application Details - K834280

Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic

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510(K) Number K834280
Device Name System, Imaging, Pulsed Echo, Ultrasonic
Applicant SHIMADZU CORP.

, US
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Regulation Number 892.1560

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Classification Product Code IYO
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Date Received 11/14/1983
Decision Date 04/25/1984
Decision SE - Substantially Equivalent
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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