| K-number | K800773 |
| Device name | DIGOCTK 125 |
| Applicant | Sorin Biomedica, Fiat, USA, Inc. |
| Product code | LCS |
| Device class | Class II |
| Decision date | Apr 24, 1980 |
| Decision | Substantially Equivalent |
| Regulation | 862.3320 |
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