The following data is part of a premarket notification filed by Totoku Electric Co., Ltd. with the FDA for 21.3 (54cm) 2m Color Lcd Monitor Ccl254i2 (cdl2125a).
| Device ID | K081055 |
| 510k Number | K081055 |
| Device Name: | 21.3 (54CM) 2M COLOR LCD MONITOR CCL254I2 (CDL2125A) |
| 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 | 2008-04-14 |
| Decision Date | 2008-06-04 |
| Summary: | summary |