Clearance Summary
POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF ID, MODEL 9043G0102 received FDA 510(k) clearance under submission number K014269, 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 2002-11-21.
- Submission: K014269
- Applicant / Sponsor: Medtronic Functional Diagnostics A/S
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1735
- Decision date: 2002-11-21
Classification & Regulation
This clearance is catalogued under FDA product code MYE and 21 CFR 876.1735, within the Gastroenterology, Urology review panel as a Class II device.