Clearance Summary
MODEL MSC SA02-5000 PULSE OXIMETER received FDA 510(k) clearance under submission number K902192, sponsored by Medical Systems Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1990-08-23.
- Submission: K902192
- Applicant / Sponsor: Medical Systems Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2700
- Decision date: 1990-08-23
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.