Clearance Summary
I.V. START KIT (AHC-50-54954 received FDA 510(k) clearance under submission number K924192, sponsored by American Healthcare Corp.. 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 1993-08-27.
- Submission: K924192
- Applicant / Sponsor: American Healthcare Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5240
- Decision date: 1993-08-27
Classification & Regulation
This clearance is catalogued under FDA product code KGX and 21 CFR 880.5240, within the General Hospital review panel as a Class I device.