3D Bolus Software— 510(k) K180289
Substantially Equivalent3D Bolus, Inc.
FDA 510(k) clearance K180289 for 3D Bolus Software, Substantially Equivalent on 2018-07-10. Applicant: 3D Bolus, Inc.. Device class: 2.
Clearance details
- Applicant
- 3D Bolus, 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
- Halifax, CA
Recent devices under product code MUJ
view allData sourced from openFDA. This site is unofficial and independent of the FDA.