INTELLISYSTEM II COLOR MONITOR
FDA 510(k) clearance K993341 · decided 1999-10-25
Clearance details
- K-number
- K993341
- Device name
- INTELLISYSTEM II COLOR MONITOR
- Applicant
- Merit Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-10-05
- Decision date
- 1999-10-25
- Days to decision
- 20 days
- Clearance type
- Special
- Product code
- MAV
- Device class
- 2
- Regulation number
- 870.1650
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- South Jordan, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| IntelliSystem II Thermal Dot Matrix printer 110 V adapter and fiber optic serial interface recall (Z-0348-06) | Merit Medical Systems, Inc | 2006-01-06 |
| IntelliSystem II Thermal Dot Matrix printer 110 V adapter and fiber optic serial interface recall (Z-0349-06) | Merit Medical Systems, Inc | 2006-01-06 |
| IntelliSystem II Thermal Dot Matrix printer 220 V 50 Hz adapter and fiber optic serial int recall (Z-0350-06) | Merit Medical Systems, Inc | 2006-01-06 |
| IntelliSystem II Thermal Dot Matrix printer 220 V 50 Hz adapter and fiber optic serial int recall (Z-0351-06) | Merit Medical Systems, Inc | 2006-01-06 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| WRAPSODY® Cell-Impermeable Endoprosthesis (P240023/S005) | Merit Medical Systems, Inc. | 2026-06-11 |
| WRAPSODY® Cell-Impermeable Endoprosthesis (P240023/S004) | Merit Medical Systems, Inc. | 2025-12-11 |
| WRAPSODY Cell-Impermeable Endoprosthesis (P240023/S001) | Merit Medical Systems, Inc. | 2025-02-12 |
| WRAPSODY Cell-Impermeable Endoprosthesis (P240023/S002) | Merit Medical Systems, Inc. | 2025-02-12 |
| WRAPSODY® Cell-Impermeable Endoprosthesis (P240023) | Merit Medical Systems, Inc. | 2024-12-19 |