Clearance Summary
EZTEST-GAS received FDA 510(k) clearance under submission number K930683, sponsored by Sgm Biomedical, Inc.. 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 1997-03-04.
- Submission: K930683
- Applicant / Sponsor: Sgm Biomedical, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2800
- Decision date: 1997-03-04
Classification & Regulation
This clearance is catalogued under FDA product code FRC and 21 CFR 880.2800, within the General Hospital review panel as a Class II device.