Ambu A/S · Class II · Cleared Sep 1, 2016
| K-number | K161656 |
| Device name | Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView Monitor |
| Applicant | Ambu A/S |
| Product code | EOQ |
| Device class | Class II |
| Decision date | Sep 1, 2016 |
| Decision | Substantially Equivalent |
| Regulation | 874.4680 |
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