The following data is part of a premarket notification filed by Epiphany Healthcare, Llc with the FDA for Epiphany Cardio Server Mobile.
| Device ID | K181720 |
| 510k Number | K181720 |
| Device Name: | Epiphany Cardio Server Mobile |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | Epiphany Healthcare, LLC 3000 E. Boundary Terrace, Suite 2 Midlothian, VA 23112 |
| Contact | Pat White |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-06-29 |
| Decision Date | 2018-07-30 |
| Summary: | summary |