Clearance Summary
BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM received FDA 510(k) clearance under submission number K954501, sponsored by Medtronic Bio-Medicus, 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 1996-01-16.
- Submission: K954501
- Applicant / Sponsor: Medtronic Bio-Medicus, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4410
- Decision date: 1996-01-16
Classification & Regulation
This clearance is catalogued under FDA product code DTY and 21 CFR 870.4410, within the Cardiovascular review panel as a Class II device.