MUSE CARDIOVASCULAR INFORMATION SYSTEM
FDA 510(k) clearance K992637 · decided 1999-11-03
Clearance details
- K-number
- K992637
- Device name
- MUSE CARDIOVASCULAR INFORMATION SYSTEM
- Applicant
- General Electric Medical Systems Information Techn
- Decision
- Substantially Equivalent
- Date received
- 1999-08-06
- Decision date
- 1999-11-03
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- DSI
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Milwaukee, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client recall (Z-1938-2025) | GE Medical Systems Information Technologies Inc | 2025-06-10 |