Clearance Summary
MEDIAID DISPOSABLE NON-ADHESIVE SENSORS, MODEL CST050-2101N; REUSABLE FINGER CLIP SP02 SENSORS, MODEL CST060-2101N received FDA 510(k) clearance under submission number K061896, sponsored by Mediaid, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2007-04-12.
- Submission: K061896
- Applicant / Sponsor: Mediaid, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2700
- Decision date: 2007-04-12
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.