ERGO SRS— 510(k) K031281
Substantially Equivalent3D Line USA, Inc.
FDA 510(k) clearance K031281 for ERGO SRS, Substantially Equivalent on 2003-12-23. Applicant: 3D Line USA, Inc.. Device class: 2.
Clearance details
- Applicant
- 3D Line USA, Inc.
- Product code
- Code MUJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Owings Mills, MD, US
Recent devices under product code MUJ
view allMore clearances from 3D Line USA, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.