The following data is part of a premarket notification filed by Totoku Electric Co., Ltd with the FDA for 21.3-inch(54 Cm) Monochrome Lcd Monitor Mdl2115a (me353i), (dv3mm-hb), (me353im).
| Device ID | K052199 |
| 510k Number | K052199 |
| Device Name: | 21.3-INCH(54 CM) MONOCHROME LCD MONITOR MDL2115A (ME353I), (DV3MM-HB), (ME353IM) |
| 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 | 2005-08-12 |
| Decision Date | 2005-09-22 |
| Summary: | summary |