510(k) K181720
K181720 is an FDA 510(k) premarket notification submitted by Epiphany Healthcare, LLC for the device "Epiphany Cardio Server Mobile". The FDA issued a decision of Substantially Equivalent on Jul 30, 2018. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 30, 2018
- Date Received
- Jun 29, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Computer, Diagnostic, Programmable
- Device Class
- Class II
- Regulation Number
- 870.1425
- Review Panel
- CV
- Submission Type
- 510(k)