The following data is part of a premarket notification filed by Electronic Business Machine Co., Ltd. (ebm) with the FDA for Uniweb, Version 5.0.
| Device ID | K071166 |
| 510k Number | K071166 |
| Device Name: | UNIWEB, VERSION 5.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | ELECTRONIC BUSINESS MACHINE CO., LTD. (EBM) 1600 KAPIOLANI BLVD. SUITE 1300 Honolulu, HI 96814 |
| Contact | Andy Yew |
| Correspondent | Andy Yew ELECTRONIC BUSINESS MACHINE CO., LTD. (EBM) 1600 KAPIOLANI BLVD. SUITE 1300 Honolulu, HI 96814 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-26 |
| Decision Date | 2007-07-23 |
| Summary: | summary |