Clearance Summary
SERIM HISENSE ULTRA 0.1, PART NUMBER 5167 received FDA 510(k) clearance under submission number K080712, sponsored by Serim Research Corp.. 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 2008-05-06.
- Submission: K080712
- Applicant / Sponsor: Serim Research Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5665
- Decision date: 2008-05-06
Classification & Regulation
This clearance is catalogued under FDA product code MSY and 21 CFR 876.5665, within the Gastroenterology, Urology review panel as a Class II device.