Clearance Summary
SYSTEM II received FDA 510(k) clearance under submission number K771372, sponsored by Irex 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 1977-08-04.
- Submission: K771372
- Applicant / Sponsor: Irex Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.2810
- Decision date: 1977-08-04
Classification & Regulation
This clearance is catalogued under FDA product code DSF and 21 CFR 870.2810, within the Cardiovascular review panel as a Class I device.