Clearance Summary
Klarity Bolus received FDA 510(k) clearance under submission number K202747, sponsored by Klarity Medical & Equipment (GZ) Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2021-05-14.
- Submission: K202747
- Applicant / Sponsor: Klarity Medical & Equipment (GZ) Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2021-05-14
Classification & Regulation
This clearance is catalogued under FDA product code IYE and 21 CFR 892.5050, within the Radiology review panel as a Class II device.