The following data is part of a premarket notification filed by Totoku Electric Co., Ltd with the FDA for 20.8-inch (53cm) Color Lcd Monitor, Models Cdl2112a, Ccl350i & Dv3mc-hb.
| Device ID | K050619 |
| 510k Number | K050619 |
| Device Name: | 20.8-INCH (53CM) COLOR LCD MONITOR, MODELS CDL2112A, CCL350I & DV3MC-HB |
| 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 | 2005-03-10 |
| Decision Date | 2005-04-26 |
| Summary: | summary |