The following data is part of a premarket notification filed by Jvckenwood Corporation with the FDA for 3mp Monochrome Digital Mammography Lcd Monitor Ms-s300.
| Device ID | K200161 |
| 510k Number | K200161 |
| Device Name: | 3MP Monochrome Digital Mammography LCD Monitor MS-S300 |
| 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 | 2020-01-22 |
| Decision Date | 2020-02-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00046838081941 | K200161 | 000 |