Clearance Summary
I.V. PRO received FDA 510(k) clearance under submission number K924180, sponsored by I.V. - Pro Tek, 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 1993-03-16.
- Submission: K924180
- Applicant / Sponsor: I.V. - Pro Tek, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5210
- Decision date: 1993-03-16
Classification & Regulation
This clearance is catalogued under FDA product code KMK and 21 CFR 880.5210, within the General Hospital review panel as a Class I device.