Clearance Summary
Kudu received FDA 510(k) clearance under submission number K151492, sponsored by R82 A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2016-05-20.
- Submission: K151492
- Applicant / Sponsor: R82 A/S
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3850
- Decision date: 2016-05-20
Classification & Regulation
This clearance is catalogued under FDA product code IOR and 21 CFR 890.3850, within the Physical Medicine review panel as a Class I device.