The following data is part of a premarket notification filed by Totoku Electric Co., Ltd with the FDA for 21,3-inch (54cm) Monochrome Lcd Monitor Me213l (mdl2108a).
| Device ID | K040695 |
| 510k Number | K040695 |
| Device Name: | 21,3-INCH (54CM) MONOCHROME LCD MONITOR ME213L (MDL2108A) |
| Classification | System, Image Processing, Radiological |
| Applicant | TOTOKU ELECTRIC CO., LTD 300 OYA Ueda, Nagano, JP 386-0192 |
| Contact | Mikio Hasegawa |
| Correspondent | Mikio Hasegawa TOTOKU 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 | 2004-03-17 |
| Decision Date | 2004-06-07 |
| Summary: | summary |