Clearance Summary
Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor received FDA 510(k) clearance under submission number K201699, sponsored by Surgical Instrument and Savings Inc (Dba Medline Renewal). The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2020-07-22.
- Submission: K201699
- Applicant / Sponsor: Surgical Instrument and Savings Inc (Dba Medline Renewal)
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2700
- Decision date: 2020-07-22
Classification & Regulation
This clearance is catalogued under FDA product code NLF and 21 CFR 870.2700, within the Cardiovascular review panel as a Class II device.