FDA 510(k) Application Details - K242545

Device Classification Name

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510(K) Number K242545
Device Name RadiForce MX317W-PA
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 PZZ
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Date Received 08/27/2024
Decision Date 05/23/2025
Decision SESE - SUBST EQUIV
Classification Advisory Committee PA - Pathology
Review Advisory Committee PA - Pathology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review

FDA Source Information for K242545


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