ERGO++ VERSION 1.7— 510(k) K080601
Substantially Equivalent3D Line Medical Systems S.R.L.
FDA 510(k) clearance K080601 for ERGO++ VERSION 1.7, Substantially Equivalent on 2008-06-06. Applicant: 3D Line Medical Systems S.R.L..
Clearance details
- Applicant
- 3D Line Medical Systems S.R.L.
- Product code
- Code MUJ
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Norcross, GA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.