510(k) K250091
K250091 is an FDA 510(k) premarket notification submitted by Korot Co., Ltd. for the device "KOROT Blood Pressure Monitor (KOROT P3 Accurate)". The FDA issued a decision of Substantially Equivalent on Mar 14, 2025. 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
- Mar 14, 2025
- Date Received
- Jan 14, 2025
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Measurement, Blood-Pressure, Non-Invasive
- Device Class
- Class II
- Regulation Number
- 870.1130
- Review Panel
- CV
- Submission Type