Clearance Summary
MODEL 700 GASTROREFLUX MONITOR/AMALYZER received FDA 510(k) clearance under submission number K822815, sponsored by Del Mar Avionics. 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 1982-10-22.
- Submission: K822815
- Applicant / Sponsor: Del Mar Avionics
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.1400
- Decision date: 1982-10-22
Classification & Regulation
This clearance is catalogued under FDA product code FFT and 21 CFR 876.1400, within the Gastroenterology, Urology review panel as a Class I device.