Clearance Summary
EQUI-GUARD (ASPIRATOR FILTER) received FDA 510(k) clearance under submission number K902089, sponsored by Equi-Tron Mfg., 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 1990-07-06.
- Submission: K902089
- Applicant / Sponsor: Equi-Tron Mfg., Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6740
- Decision date: 1990-07-06
Classification & Regulation
This clearance is catalogued under FDA product code GCX and 21 CFR 880.6740, within the General Hospital review panel as a Class II device.