Healcerion Co., Ltd. · Class II · Cleared Oct 12, 2017
| K-number | K170085 |
| Device name | SONON Ultrasound Imaging System, Model: 300L |
| Applicant | Healcerion Co., Ltd. |
| Product code | IYN |
| Device class | Class II |
| Decision date | Oct 12, 2017 |
| 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