Clearance Summary
MINOLTA PULSOX-3/MINOLTA PULSOX-3I received FDA 510(k) clearance under submission number K984570, sponsored by In-X 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 2000-08-30.
- Submission: K984570
- Applicant / Sponsor: In-X Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2700
- Decision date: 2000-08-30
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.