The following data is part of a premarket notification filed by Totoku Electric Co., Ltd with the FDA for Monochrome Perfectly Flat Panel Displays, Me Series.
| Device ID | K012099 |
| 510k Number | K012099 |
| Device Name: | MONOCHROME PERFECTLY FLAT PANEL DISPLAYS, ME SERIES |
| Classification | System, Image Processing, Radiological |
| Applicant | TOTOKU ELECTRIC CO., LTD 319 AKENO OBATA-CHO, WATARAI-GUN Mieken, JP 519-05 |
| Contact | Mikio Hasegawa |
| Correspondent | Mikio Hasegawa TOTOKU ELECTRIC CO., LTD 319 AKENO OBATA-CHO, WATARAI-GUN Mieken, JP 519-05 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-05 |
| Decision Date | 2001-07-31 |
| Summary: | summary |