The following data is part of a premarket notification filed by Totoku Electric Co., Ltd. with the FDA for 21.3 Inch (54 Cm) Monochrome Lcd Monitor Ms23i2 (ml21023).
| Device ID | K113443 |
| 510k Number | K113443 |
| Device Name: | 21.3 INCH (54 CM) MONOCHROME LCD MONITOR MS23I2 (ML21023) |
| Classification | System, Image Processing, Radiological |
| Applicant | TOTOKU ELECTRIC CO., LTD. 300 OYA Ueda, JP 386-0192 |
| Contact | Tsukasa Tashiro |
| Correspondent | Tsukasa Tashiro TOTOKU ELECTRIC CO., LTD. 300 OYA Ueda, 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 | 2011-11-21 |
| Decision Date | 2011-12-23 |
| Summary: | summary |