The following data is part of a premarket notification filed by Innolux Corporation with the FDA for Innolux Ric.
Device ID | K162344 |
510k Number | K162344 |
Device Name: | INNOLUX RIC |
Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
Applicant | INNOLUX CORPORATION No. 3, Sec. 1, Huansi Rd. Tainan City, Southern Taiwan Science Par, TW 74147 |
Contact | Andy Kuo |
Correspondent | Andy Kuo INNOLUX CORPORATION No. 3, Sec. 1, Huansi Rd. Tainan City, Southern Taiwan Science Par, TW 74147 |
Product Code | MQB |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-08-22 |
Decision Date | 2016-12-20 |