Clearance Summary
GAS-VAK(R) COMBINATION STERILIZER & VENTILATOR received FDA 510(k) clearance under submission number K902906, sponsored by Gas-Vak. 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 1990-10-15.
- Submission: K902906
- Applicant / Sponsor: Gas-Vak
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6100
- Decision date: 1990-10-15
Classification & Regulation
This clearance is catalogued under FDA product code FLI and 21 CFR 880.6100, within the General Hospital review panel as a Class II device.