The following data is part of a premarket notification filed by Totoku Electric Co., Ltd with the FDA for 21.3-inch (54cm) Color Lcd Monitor Cdl2120a (ccl252i2).
Device ID | K063199 |
510k Number | K063199 |
Device Name: | 21.3-INCH (54CM) COLOR LCD MONITOR CDL2120A (CCL252I2) |
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 | 2006-12-04 |
Summary: | summary |