Clearance Summary
POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103 received FDA 510(k) clearance under submission number K010130, sponsored by Medtronic Functional Diagnostics A/S. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2001-02-07.
- Submission: K010130
- Applicant / Sponsor: Medtronic Functional Diagnostics A/S
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1725
- Decision date: 2001-02-07
Classification & Regulation
This clearance is catalogued under FDA product code FFX and 21 CFR 876.1725, within the Gastroenterology, Urology review panel as a Class II device.