FDA 510(k) Application Details - K222864

Device Classification Name

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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
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Contact Hideki Tengeiji
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Regulation Number

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Classification Product Code PGY
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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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