Bk Medical Aps · Class II · Cleared Oct 5, 2015
| K-number | K151910 |
| Device name | Ultrasound Scanner System BK2300 |
| Applicant | Bk Medical Aps |
| Product code | IYN |
| Device class | Class II |
| Decision date | Oct 5, 2015 |
| Decision | Substantially Equivalent |
| Regulation | 892.1550 |
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