The following data is part of a premarket notification filed by Jvc Kenwood Corporation with the FDA for 2mp Color Lcd Monitor Cl-s200, 3mp Color Lcd Monitor Cl-s300.
| Device ID | K173434 |
| 510k Number | K173434 |
| Device Name: | 2MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300 |
| Classification | Display, Diagnostic Radiology |
| Applicant | JVC KENWOOD Corporation 3-12, Moriya-cho, Kanagawa-ku Yokohama, JP 221-0022 |
| Contact | Masafumi Yugami |
| Correspondent | Masafumi Yugami 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 | 2017-11-02 |
| Decision Date | 2017-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00046838078880 | K173434 | 000 |
| 00046838077531 | K173434 | 000 |
| 00046838077524 | K173434 | 000 |