The following data is part of a premarket notification filed by Jvc Kenwood Corporation with the FDA for 5mp Color Lcd Monitor Cl-s500, 5mp Monochrome Lcd Monitor Ms-s500.
| Device ID | K191137 |
| 510k Number | K191137 |
| Device Name: | 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500 |
| Classification | Display, Diagnostic Radiology |
| Applicant | JVC Kenwood Corporation 3-12, Moriya-cho, Kanagawa-ku Yokohama, JP 221-0022 |
| Contact | Hideki Tengeiji |
| Correspondent | Hideki Tengeiji JVC Kenwood Corporation 3-12, Moriya-cho, Kanagawa-ku Yokohama, JP 221-0022 |
| Product Code | PGY |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-29 |
| Decision Date | 2019-07-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00046838081033 | K191137 | 000 |
| 00046838081026 | K191137 | 000 |
| 00046838079979 | K191137 | 000 |
| 00046838079962 | K191137 | 000 |