Clearance Summary
APEXNRG XFR received FDA 510(k) clearance under submission number K063843, sponsored by Medicnrg , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 2007-01-03.
- Submission: K063843
- Applicant / Sponsor: Medicnrg , Ltd.
- Clearance pathway: Special
- Review panel: Unknown
- Device class:
- Decision date: 2007-01-03
Classification & Regulation
This clearance is catalogued under FDA product code LQY , within the Unknown review panel as a device.