K240319
- 510(k) number
- K240319
- Device name
- DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)
- Applicant
- Pro Med Instruments GmbH DE
- Product code
- HBL — Holder, Head, Neurosurgical (Skull Clamp)
- Decision date
- 2024-04-24
- Date received
- 2024-02-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K240319.pdf
Official FDA record: K240319
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.