510(k) K242568
K242568 is an FDA 510(k) premarket notification submitted by Shenzhen Zhongkemingwang Telecommunications Software Corp. for the device "Wrist Blood Pressure Monitor (OHMS11, OHMS12)". The FDA issued a decision of Substantially Equivalent on January 30, 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
- January 30, 2025
- Date Received
- August 29, 2024
- 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