Clearance Summary
VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor received FDA 510(k) clearance under submission number K221267, sponsored by Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2022-12-15.
- Submission: K221267
- Applicant / Sponsor: Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 2022-12-15
Classification & Regulation
This clearance is catalogued under FDA product code MWI and 21 CFR 870.2300, within the Cardiovascular review panel as a Class II device.