Clearance Summary
STIHLER ASTOTHERM IFT 200, IFT 220 received FDA 510(k) clearance under submission number K882361, sponsored by Stihler Electronic, C/O Worldwide Regul. Services. 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 1988-08-25.
- Submission: K882361
- Applicant / Sponsor: Stihler Electronic, C/O Worldwide Regul. Services
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 1988-08-25
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.