The following data is part of a premarket notification filed by Tokotu Electric Co., Ltd. with the FDA for 21.3 Inch (53cm) Monochrome Digital Mammography Lcd Monitor Ms51i2, (mdl2123a).
| Device ID | K081242 |
| 510k Number | K081242 |
| Device Name: | 21.3 INCH (53CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS51I2, (MDL2123A) |
| Classification | System, Image Processing, Radiological |
| Applicant | TOKOTU ELECTRIC CO., LTD. 300 OYA, UEDA Nagano, JP 386-0192 |
| Contact | Mikio Hasegawa |
| Correspondent | Mikio Hasegawa TOKOTU ELECTRIC CO., LTD. 300 OYA, UEDA Nagano, JP 386-0192 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-01 |
| Decision Date | 2008-06-11 |
| Summary: | summary |