The following data is part of a premarket notification filed by Totoku Electric Co., Ltd with the FDA for 20.8-inch (53cm) Color Lcd Monitor Cdl2119a (ccl352i2).
Device ID | K072065 |
510k Number | K072065 |
Device Name: | 20.8-INCH (53CM) COLOR LCD MONITOR CDL2119A (CCL352I2) |
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 | 2007-07-27 |
Decision Date | 2007-08-14 |
Summary: | summary |