Clearance Summary
MACHIDA AMERICA MODEL AC-5000 AUTOMATIC DISINFECT. received FDA 510(k) clearance under submission number K871712, sponsored by Machida America, 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 1988-01-14.
- Submission: K871712
- Applicant / Sponsor: Machida America, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1988-01-14
Classification & Regulation
This clearance is catalogued under FDA product code NVE and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.