Sorin Biomedica, Fiat, USA, Inc. · Class III · Cleared Jan 14, 1986
| K-number | K852641 |
| Device name | ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER |
| Applicant | Sorin Biomedica, Fiat, USA, Inc. |
| Product code | DXY |
| Device class | Class III |
| Decision date | Jan 14, 1986 |
| Decision | Substantially Equivalent |
| Regulation | 870.3610 |
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