Clearance Summary
OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR received FDA 510(k) clearance under submission number K881004, sponsored by Keymed, 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 1988-05-12.
- Submission: K881004
- Applicant / Sponsor: Keymed, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1988-05-12
Classification & Regulation
This clearance is catalogued under FDA product code FCX and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.