Clearance Summary
BUZZY BEAR ENURESIS ALARM received FDA 510(k) clearance under submission number K895852, sponsored by Med-Design, 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 1990-02-12.
- Submission: K895852
- Applicant / Sponsor: Med-Design, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.2040
- Decision date: 1990-02-12
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.