| K-number | K914935 |
| Device name | HEART PACK II |
| Applicant | Westmark Hospital Supplies |
| Product code | LRO |
| Device class | Class II |
| Decision date | Jan 31, 1992 |
| Decision | Substantially Equivalent — Kit Device |
| Regulation | 878.4370 |
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