Clearance Summary
ASTOTHERM IFT 250, IFT 260, ASTOTUBE VARIOUS NO. received FDA 510(k) clearance under submission number K914364, sponsored by North American Technical Services Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1992-09-10.
- Submission: K914364
- Applicant / Sponsor: North American Technical Services Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 1992-09-10
Classification & Regulation
This clearance is catalogued under FDA product code LGZ and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.