Clearance Summary
Halo received FDA 510(k) clearance under submission number K150486, sponsored by J & J Solutions, Inc. D/B/A/ Corvida Medical. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2015-07-24.
- Submission: K150486
- Applicant / Sponsor: J & J Solutions, Inc. D/B/A/ Corvida Medical
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2015-07-24
Classification & Regulation
This clearance is catalogued under FDA product code ONB and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.