Clearance Summary
MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE received FDA 510(k) clearance under submission number K022677, sponsored by Alaris Medical Systems, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2002-09-11.
- Submission: K022677
- Applicant / Sponsor: Alaris Medical Systems, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2700
- Decision date: 2002-09-11
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.