FDA 510(k) Application Details - K160326

Device Classification Name

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510(K) Number K160326
Device Name 5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550)
Applicant JVC KENWOOD Corporation
3-12, Moriya-cho, Kanagawa-ku
Yokohama 221-0022 JP
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Contact Tsukasa Tashiro
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Regulation Number

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Classification Product Code PGY
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Date Received 02/05/2016
Decision Date 02/23/2016
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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