The following data is part of a premarket notification filed by Jvc Kenwood Corporation with the FDA for 5mp Monochrome Lcd Monitor Ms55i2, 5mp Color Lcd Monitor Ccl550i2 (cl21550).
| Device ID | K160326 |
| 510k Number | K160326 |
| Device Name: | 5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550) |
| 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 | 2016-02-05 |
| Decision Date | 2016-02-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00805736045413 | K160326 | 000 |
| 00046838076381 | K160326 | 000 |
| 00046838076411 | K160326 | 000 |
| 00046838076435 | K160326 | 000 |
| 04996005102886 | K160326 | 000 |
| 04996005102893 | K160326 | 000 |
| 04996005102909 | K160326 | 000 |
| 04996005103524 | K160326 | 000 |
| 04996005103531 | K160326 | 000 |
| 04996005103555 | K160326 | 000 |
| 00046838076374 | K160326 | 000 |