FDA 510(k) Application Details - K837304

Device Classification Name

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510(K) Number K837304
Device Name MODELS 246 AND 210F LINEAR ARRAY ULTRASOUND SCANNER
Applicant ALOKA CO., LTD.
6-22-1, MURE, MITAKA-SHI
TOKYO 181 JA
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Regulation Number

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Classification Product Code
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Date Received 03/18/1983
Decision Date 05/09/1983
Decision SE - Substantially Equivalent
Classification Advisory Committee RA - Radiology
Review Advisory Committee -
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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