FDA 510(k) Application Details - K233465

Device Classification Name

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510(K) Number K233465
Device Name RadiForce MX317W
Applicant EIZO Corporation
153 Shimokashiwano
Hakusan, Ishikawa 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 10/24/2023
Decision Date 12/21/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review

FDA Source Information for K233465


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