The following data is part of a premarket notification filed by Totoku Electric Co., Ltd with the FDA for 5m Medical Flat Panel Display, Me511l.
| Device ID | K031661 |
| 510k Number | K031661 |
| Device Name: | 5M MEDICAL FLAT PANEL DISPLAY, ME511L |
| Classification | System, Image Processing, Radiological |
| Applicant | TOTOKU ELECTRIC CO., LTD 300 OYA , UEDA-SHI, Nagano-ken, JP 386-0192 |
| Contact | Mikio Hasegawa |
| Correspondent | Mikio Hasegawa TOTOKU ELECTRIC CO., LTD 300 OYA , UEDA-SHI, Nagano-ken, 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 | 2003-05-28 |
| Decision Date | 2004-04-23 |
| Summary: | summary |