510(k) K250136
K250136 is an FDA 510(k) premarket notification submitted by Globalcare Medical Technology Co., Ltd. for the device "Globalcare Blood Pressure Monitor (GUS610)". The FDA issued a decision of Substantially Equivalent on April 8, 2025. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Globalcare Medical Technology Co., Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 8, 2025
- Date Received
- January 17, 2025
- Clearance Type
- Special
- 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