Clearance Summary
HIFLO-HP received FDA 510(k) clearance under submission number K812457, sponsored by Tri-Med, 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 1981-09-21.
- Submission: K812457
- Applicant / Sponsor: Tri-Med, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 1981-09-21
Classification & Regulation
This clearance is catalogued under FDA product code FPB and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.