The following data is part of a premarket notification filed by Totoku Electric Co., Ltd with the FDA for 3m Color Medical Flat Panel Display, Ccl316.
Device ID | K032555 |
510k Number | K032555 |
Device Name: | 3M COLOR MEDICAL FLAT PANEL DISPLAY, CCL316 |
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 | 2003-08-19 |
Decision Date | 2004-02-26 |