510(k) K163694
K163694 is an FDA 510(k) premarket notification submitted by Rooti Labs , Ltd. for the device "Rooti Rx ECG Event Recorder, Rooti Link APP Software". The FDA issued a decision of Substantially Equivalent on Nov 7, 2017. The device falls under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency), a Class II device regulated under 21 CFR 870.2910.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 7, 2017
- Date Received
- Dec 28, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transmitters And Receivers, Physiological Signal, Radiofrequency
- Device Class
- Class II
- Regulation Number
- 870.2910
- Review Panel
- CV
- Submission Type
- 510(k)