Clearance Summary
FLU MET 2 received FDA 510(k) clearance under submission number K842088, sponsored by Venusa , Ltd.. 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 1984-08-17.
- Submission: K842088
- Applicant / Sponsor: Venusa , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 1984-08-17
Classification & Regulation
This clearance is catalogued under FDA product code FPA and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.