The following data is part of a premarket notification filed by Jvckenwood Corporation with the FDA for 8mp Color Lcd Monitor Cl-r813.
| Device ID | K222864 |
| 510k Number | K222864 |
| Device Name: | 8MP Color LCD Monitor CL-R813 |
| Classification | Display, Diagnostic Radiology |
| Applicant | JVCKENWOOD Corporation 3-12, Moriya-cho, Kanagawa-ku Yokohama, JP 221-0022 |
| Contact | Hideki Tengeiji |
| Correspondent | Hideki Tengeiji JVCKENWOOD 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 | 2022-09-22 |
| Decision Date | 2022-12-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00046838002687 | K222864 | 000 |