The following data is part of a premarket notification filed by Client Outlook Inc. with the FDA for Eunity.
| Device ID | K161515 |
| 510k Number | K161515 |
| Device Name: | EUnity |
| Classification | System, Image Processing, Radiological |
| Applicant | Client Outlook Inc. 103 Bauer Place, Suite #3 Waterloo, CA N2l6b5 |
| Contact | Christie Eby |
| Correspondent | Christie Eby Client Outlook Inc. 103 Bauer Place, Suite #3 Waterloo, CA N2l6b5 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-02 |
| Decision Date | 2016-11-15 |