Clearance Summary
SpO2 Extension Cable received FDA 510(k) clearance under submission number K242986, sponsored by Beijing Rongrui-Century Science & Technology Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2025-05-02.
- Submission: K242986
- Applicant / Sponsor: Beijing Rongrui-Century Science & Technology Co., Ltd.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2900
- Decision date: 2025-05-02
Classification & Regulation
This clearance is catalogued under FDA product code DSA and 21 CFR 870.2900, within the Cardiovascular review panel as a Class II device.