K973230 is an FDA 510(k) clearance for the MONARCH (IN 2125)/INTELLISYSTEM (IN 1125). This device is classified as a Injector And Syringe, Angiographic (Class II - Special Controls, product code DXT).
Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on November 25, 1997, 90 days after receiving the submission on August 27, 1997.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K973230 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 27, 1997 |
| Decision Date | November 25, 1997 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXT — Injector And Syringe, Angiographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1650 |