Clearance Summary
DORO HEADREST SYSTEM received FDA 510(k) clearance under submission number K001808, 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 2000-08-04.
- Submission: K001808
- Applicant / Sponsor: Pro-Med Instruments GmbH
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4460
- Decision date: 2000-08-04
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.