Clearance Summary
DORO QR3 XTom Headholder System received FDA 510(k) clearance under submission number K191979, sponsored by Pro Med Instruments GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2019-10-22.
- Submission: K191979
- Applicant / Sponsor: Pro Med Instruments GmbH
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4460
- Decision date: 2019-10-22
Classification & Regulation
This clearance is catalogued under FDA product code HBL and 21 CFR 882.4460, within the Neurology review panel as a Class II device.