510(k) K182571
K182571 is an FDA 510(k) premarket notification submitted by Genetesis, Inc. for the device "CardioFlux with Faraday Analytical Cloud". The FDA issued a decision of Substantially Equivalent on Mar 15, 2019. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 15, 2019
- Date Received
- Sep 18, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2340
- Review Panel
- CV
- Submission Type
- 510(k)