Clearance Summary
NEURO URODYNAMIC SUITE, MODEL 9032E0101 received FDA 510(k) clearance under submission number K992715, sponsored by Medtronic Functional Diagnostics A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2000-02-28.
- Submission: K992715
- Applicant / Sponsor: Medtronic Functional Diagnostics A/S
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1620
- Decision date: 2000-02-28
Classification & Regulation
This clearance is catalogued under FDA product code FEN and 21 CFR 876.1620, within the Gastroenterology, Urology review panel as a Class II device.