K230148
- 510(k) number
- K230148
- Device name
- Vlab
- Applicant
- Dormotech Medical, Ltd. IL
- Product code
- GWL — Amplifier, Physiological Signal
- Decision date
- 2023-10-11
- Date received
- 2023-01-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K230148.pdf
Official FDA record: K230148
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.