The following data is part of a premarket notification filed by Totoku Electric Co., Ltd with the FDA for 1.3m Monochrome Lcd Monitor Mdl1908a.
Device ID | K072066 |
510k Number | K072066 |
Device Name: | 1.3M MONOCHROME LCD MONITOR MDL1908A |
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 |