K993341 is an FDA 510(k) clearance for the INTELLISYSTEM II COLOR MONITOR. This device is classified as a Syringe, Balloon Inflation (Class II - Special Controls, product code MAV).
Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on October 25, 1999, 20 days after receiving the submission on October 5, 1999.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K993341 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 05, 1999 |
| Decision Date | October 25, 1999 |
| Days to Decision | 20 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MAV — Syringe, Balloon Inflation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1650 |