| K-number | K000503 |
| Device name | MEDART 520 COOLING SYSTEM |
| Applicant | Medart Corp. |
| Product code | GEX |
| Device class | Class II |
| Decision date | May 15, 2000 |
| Decision | Substantially Equivalent |
| Regulation | 878.4810 |
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