Clearance Summary
HARVARD 2 SYRINGE PUMP, MODEL 2001-001 received FDA 510(k) clearance under submission number K050107, sponsored by Harvard Clinical Technology. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2005-02-11.
- Submission: K050107
- Applicant / Sponsor: Harvard Clinical Technology
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2005-02-11
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.