The following data is part of a premarket notification filed by Eizo Corporation with the FDA for 2mp Color Lcd Monitor, Radiforce Rs240.
Device ID | K150106 |
510k Number | K150106 |
Device Name: | 2MP Color LCD Monitor, RadiForce RS240 |
Classification | Display, Diagnostic Radiology |
Applicant | EIZO CORPORATION 153 SHIMOKASHIWANO Hakusan, JP 924-8566 |
Contact | Hiroaki Hashimoto |
Correspondent | Hiroaki Hashimoto EIZO CORPORATION 153 SHIMOKASHIWANO Hakusan, JP 924-8566 |
Product Code | PGY |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-01-20 |
Decision Date | 2015-04-03 |
Summary: | summary |