Sterilmed, Inc. · Class II · Cleared Nov 21, 2016
| K-number | K161700 |
| Device name | SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters |
| Applicant | Sterilmed, Inc. |
| Product code | OWQ |
| Device class | Class II |
| Decision date | Nov 21, 2016 |
| Decision | Substantially Equivalent |
| Regulation | 870.1200 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov