510(k) K230996
K230996 is an FDA 510(k) premarket notification submitted by Pursuant Health for the device "Pursuant Health Kiosk (G1.D5)". The FDA issued a decision of Substantially Equivalent on January 4, 2024. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 4, 2024
- Date Received
- April 7, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Measurement, Blood-Pressure, Non-Invasive
- Device Class
- Class II
- Regulation Number
- 870.1130
- Review Panel
- CV
- Submission Type