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, Models Mdl2109a, Me251i & Dv2mm-hb.
| Device ID | K050617 |
| 510k Number | K050617 |
| Device Name: | 21.3-INCH (54CM) MONOCHROME LCD MONITOR, MODELS MDL2109A, ME251I & DV2MM-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 | 2005-04-22 |
| Summary: | summary |