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 Mdl2118a (me355i2).
| Device ID | K063197 |
| 510k Number | K063197 |
| Device Name: | 21.3 INCH (54CM) MONOCHROME LCD MONITOR MDL2118A (ME355I2) |
| 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 | 2006-10-20 |
| Decision Date | 2006-11-30 |
| Summary: | summary |