Clearance Summary
Sterile LeadConfirm received FDA 510(k) clearance under submission number K191739, sponsored by Alpha Omega Engineering , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2020-01-02.
- Submission: K191739
- Applicant / Sponsor: Alpha Omega Engineering , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1330
- Decision date: 2020-01-02
Classification & Regulation
This clearance is catalogued under FDA product code GZL and 21 CFR 882.1330, within the Neurology review panel as a Class II device.