The following data is part of a premarket notification filed by Ebm Technologies Incorporated with the FDA for Uniweb 8.0.
Device ID | K142514 |
510k Number | K142514 |
Device Name: | UniWeb 8.0 |
Classification | System, Image Processing, Radiological |
Applicant | EBM Technologies Incorporated 5F., No. 516, Sec. 1, Neihu Rd., Neihu Dist. Taipei, TW |
Contact | John Su |
Correspondent | John Su EBM Technologies Incorporated 5F., No. 516, Sec. 1, Neihu Rd., Neihu Dist. Taipei, TW |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-09-08 |
Decision Date | 2014-12-18 |