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FDA 510(k) Application Details - K222864
Device Classification Name
More FDA Info for this Device
510(K) Number
K222864
Device Name
8MP Color LCD Monitor CL-R813
Applicant
JVCKENWOOD Corporation
3-12, Moriya-cho, Kanagawa-ku
Yokohama 221-0022 JP
Other 510(k) Applications for this Company
Contact
Hideki Tengeiji
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PGY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/22/2022
Decision Date
12/21/2022
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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