The following data is part of a premarket notification filed by Eizo Corporation with the FDA for 3mp Color Lcd Monitor, Radiforce Rs340.
Device ID | K143098 |
510k Number | K143098 |
Device Name: | 3MP Color LCD Monitor, RadiForce RS340 |
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 | 2014-10-28 |
Decision Date | 2014-11-18 |
Summary: | summary |