E3 and Profile— 510(k) K221471
Substantially EquivalentDiagnosys, LLC
FDA 510(k) clearance K221471 for E3 and Profile, Substantially Equivalent on 2022-11-22. Applicant: Diagnosys, LLC.
Clearance details
- Applicant
- Diagnosys, LLC
- Product code
- Code GWE
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lowell, MA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.