L300 Go System— 510(k) K190285
Substantially EquivalentBioness, Inc.
FDA 510(k) clearance K190285 for L300 Go System, Substantially Equivalent on 2019-03-14. Applicant: Bioness, Inc.. Device class: 2.
Clearance details
- Applicant
- Bioness, Inc.
- Product code
- Code GZI
- Device class
- Class 2
- Regulation
- 21 CFR 882.5810
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Valencia, CA, US
Recent devices under product code GZI
view allMore clearances from Bioness, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.