510(k) K250548
K250548 is an FDA 510(k) premarket notification submitted by Joytech Healthcare Co. , Ltd. for the device "Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)". The FDA issued a decision of Substantially Equivalent on Jun 26, 2025. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Joytech Healthcare Co. , Ltd. has 22 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 26, 2025
- Date Received
- Feb 25, 2025
- 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
- 510(k)