Philips Medical Systems Nederland B.V. · Class II · Cleared Apr 10, 2020
| K-number | K193215 |
| Device name | Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems |
| Applicant | Philips Medical Systems Nederland B.V. |
| Product code | LNH |
| Device class | Class II |
| Decision date | Apr 10, 2020 |
| Decision | Substantially Equivalent |
| Regulation | 892.1000 |
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