FDA 510(k) Application Details - K210345

Device Classification Name

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510(K) Number K210345
Device Name 2MP Monochrome LCD Monitor MS-S200
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 02/05/2021
Decision Date 04/23/2021
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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