Clearance Summary
SHENZHEN MED-LINK PULSE OXIMETER PROBE received FDA 510(k) clearance under submission number K113727, sponsored by Shenzhen Med-Link Electronics Tech 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 2013-03-21.
- Submission: K113727
- Applicant / Sponsor: Shenzhen Med-Link Electronics Tech Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2700
- Decision date: 2013-03-21
Classification & Regulation
This clearance is catalogued under FDA product code DQA and 21 CFR 870.2700, within the Cardiovascular review panel as a Class II device.