510(k) clearance
DORO® Headrest System for AVA
- 510(k) number
- K262229
- Applicant
- Black Forest Medical GmbH
- Decision date
- Oct 27, 2026
- Date received
- Jun 30, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- HBL
- Device type
- Holder, Head, Neurosurgical (Skull Clamp)
- Device class
- Class II
- Regulation
- 21 CFR 882.4460
- Advisory committee
- Neurology
- Statement or summary
- Summary
- Third party
- N
- Location
- Freiburg, DE