Clearance Summary
NITE TRAIN'R received FDA 510(k) clearance under submission number K780660, sponsored by Nite Train-R Enterprises, Inc.. 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 1978-07-28.
- Submission: K780660
- Applicant / Sponsor: Nite Train-R Enterprises, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.2040
- Decision date: 1978-07-28
Classification & Regulation
This clearance is catalogued under FDA product code KPN and 21 CFR 876.2040, within the Gastroenterology, Urology review panel as a Class II device.