The following data is part of a premarket notification filed by Client Outlook Inc. with the FDA for Eunity.
| Device ID | K172490 |
| 510k Number | K172490 |
| Device Name: | EUnity |
| Classification | System, Image Processing, Radiological |
| Applicant | Client Outlook Inc. 103 Bauer Place, Suite #3 Waterloo, CA N2t 2v2 |
| Contact | Christie Eby |
| Correspondent | Christie Eby Client Outlook Inc. 103 Bauer Place, Suite #3 Waterloo, CA N2t 2v2 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-17 |
| Decision Date | 2018-02-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868772000174 | K172490 | 000 |