510(k) K222160
K222160 is an FDA 510(k) premarket notification submitted by Globalcare Medical Technology Co., Ltd. for the device "GUS610 Blood pressure monitor". The FDA issued a decision of Substantially Equivalent on November 22, 2022. 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
- November 22, 2022
- Date Received
- July 20, 2022
- 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