Device Classification Name |
Display, Diagnostic Radiology
|
510(k) Number |
K210345 |
Device Name |
2MP Monochrome LCD Monitor MS-S200 |
Applicant |
Jvckenwood Corporation |
3-12, Moriya-cho, Kanagawa-ku |
Yokohama,
JP
221-0022
|
|
Applicant Contact |
Hideki Tengeiji |
Correspondent |
Jvckenwood Corporation |
3-12, Moriya-cho, Kanagawa-ku |
Yokohama,
JP
221-0022
|
|
Correspondent Contact |
Hideki Tengeiji |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 02/05/2021 |
Decision Date | 04/23/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|