K220735
- 510(k) number
- K220735
- Device name
- Avologi Gel Primer (Model: Av25)
- Applicant
- Premier North America, Inc. FL · US
- Product code
- GYB — Media, Electroconductive
- Decision date
- 2023-09-15
- Date received
- 2022-03-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K220735.pdf
Official FDA record: K220735
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.