• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name display, diagnostic radiology
510(k) Number K191137
Device Name 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500
Applicant
JVC Kenwood Corporation
3-12, Moriya-cho, Kanagawa-ku
yokohama,  JP 221-0022
Applicant Contact hideki tengeiji
Correspondent
JVC Kenwood Corporation
3-12, Moriya-cho, Kanagawa-ku
yokohama,  JP 221-0022
Correspondent Contact hideki tengeiji
Regulation Number892.2050
Classification Product Code
PGY  
Date Received04/29/2019
Decision Date 07/02/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-