510(k) K193343
Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed) by
Vitalconnect, Inc.
— Product Code DRG
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 20, 2020
- Date Received
- December 3, 2019
- 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