Clearance Summary
MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE received FDA 510(k) clearance under submission number K101280, sponsored by Midwest Reprocessing Center, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2010-10-07.
- Submission: K101280
- Applicant / Sponsor: Midwest Reprocessing Center, LLC
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2700
- Decision date: 2010-10-07
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.