Clearance Summary
hipEOS received FDA 510(k) clearance under submission number K161479, sponsored by Onefit Medical. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2016-06-28.
- Submission: K161479
- Applicant / Sponsor: Onefit Medical
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2016-06-28
Classification & Regulation
This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.