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FDA 510(k) Application Details - K180961
Device Classification Name
More FDA Info for this Device
510(K) Number
K180961
Device Name
RadiForce MX194
Applicant
EIZO Corporation
153 Shimokashiwano
Hakusan 924-8566 JP
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Contact
Hiroaki Hashimoto
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
PGY
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More FDA Info for this Product Code
Date Received
04/12/2018
Decision Date
05/10/2018
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
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