FDA 510(k) Application Details - K172738

Device Classification Name

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510(K) Number K172738
Device Name RadiForce RX560, RX560-AR
Applicant EIZO Corporation
153 Shimokashiwano
Hakusan 924-8566 JP
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Contact Hiroaki Hashimoto
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Regulation Number

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Classification Product Code PGY
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Date Received 09/12/2017
Decision Date 11/08/2017
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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