Clearance Summary
PATIENT ISOLATION UNIT, MODEL G019-1000 received FDA 510(k) clearance under submission number K080117, sponsored by Gentex Corporation. 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 2009-01-30.
- Submission: K080117
- Applicant / Sponsor: Gentex Corporation
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5450
- Decision date: 2009-01-30
Classification & Regulation
This clearance is catalogued under FDA product code LGM and 21 CFR 880.5450, within the General Hospital review panel as a Class II device.