The following data is part of a premarket notification filed by Client Outlook Inc with the FDA for Eunity.
| Device ID | K111164 |
| 510k Number | K111164 |
| Device Name: | EUNITY |
| Classification | System, Image Processing, Radiological |
| Applicant | CLIENT OUTLOOK INC 295 HAGEY BLVD Waterloo, CA N2l 6r5 |
| Contact | Christie Eby |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-04-26 |
| Decision Date | 2011-05-06 |