The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Intellisystem Ii Color Monitor.
| Device ID | K993341 |
| 510k Number | K993341 |
| Device Name: | INTELLISYSTEM II COLOR MONITOR |
| Classification | Syringe, Balloon Inflation |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Contact | Chester Mccoy |
| Correspondent | Chester Mccoy MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Product Code | MAV |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-05 |
| Decision Date | 1999-10-25 |
| Summary: | summary |