The following data is part of a premarket notification filed by Totoku Electric Co., Ltd with the FDA for 21.3 Inch (54 Cm) Color Lcd Monitor Ccl356i2 (cl21356).
Device ID | K112604 |
510k Number | K112604 |
Device Name: | 21.3 INCH (54 CM) COLOR LCD MONITOR CCL356I2 (CL21356) |
Classification | System, Image Processing, Radiological |
Applicant | TOTOKU ELECTRIC CO., LTD 300 OYA Ueda, Nagano, JP 386-0192 |
Contact | Tsukasa Tashiro |
Correspondent | Tsukasa Tashiro 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 | 2011-09-07 |
Decision Date | 2011-10-27 |
Summary: | summary |