Clearance Summary
MTP TRANSPORT INFUSION PUMP, MODEL NO. MTPLEA received FDA 510(k) clearance under submission number K910335, sponsored by Medical Technical Products. 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 1991-03-13.
- Submission: K910335
- Applicant / Sponsor: Medical Technical Products
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 1991-03-13
Classification & Regulation
This clearance is catalogued under FDA product code FRN and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.