The following data is part of a premarket notification filed by Jvc Kenwood Corporation with the FDA for 2mp Color Lcd Monitor Ccl214 (cl21214).
| Device ID | K161895 |
| 510k Number | K161895 |
| Device Name: | 2MP Color LCD Monitor CCL214 (CL21214) |
| Classification | Display, Diagnostic Radiology |
| Applicant | JVC KENWOOD Corporation 3-12, Moriya-cho, Kanagawa-ku Yokohama, JP 221-0022 |
| Contact | Tsukasa Tashiro |
| Correspondent | Tsukasa Tashiro 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 | 2016-07-11 |
| Decision Date | 2016-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04996005103562 | K161895 | 000 |
| 00046838076626 | K161895 | 000 |