MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE
FDA 510(k) clearance K083639 · decided 2009-02-17
Clearance details
- K-number
- K083639
- Device name
- MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE
- Applicant
- Ge Medical Systems Information Technologies
- Decision
- Substantially Equivalent
- Date received
- 2008-12-09
- Decision date
- 2009-02-17
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- DQK
- Device class
- 2
- Regulation number
- 870.1425
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Wauwatosa, WI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ge Medical Systems Information Technologies
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GE Healthcare Muse v7 cardiology information system. Model number 2026443-001: MUSE 7.0 ap recall (Z-1133-2013) | GE Healthcare, LLC | 2013-04-17 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| COROMETRICS MODEL 120 F-SERIES MATERNAL/FETAL MONITOR WITH INTERGRATED FETAL OXYGEN SATURATION MONITORING (P000016/S002) | Ge Medical Systems Information Technologies | 2003-10-15 |
| COROMETRICS MODEL 120 SERIES MATERNAL/FETAL MONITOR W/INTEGRATED FETAL PULSE OXIMETRY (P000016/S001) | Ge Medical Systems Information Technologies | 2001-11-09 |
| COROMETRICS 120F SERIES MATERNAL/FETAL MONITOR (P000016) | Ge Medical Systems Information Technologies | 2001-02-09 |
| MODEL 515 NEONATAL MONIOTR (P840037/S001) | Ge Medical Systems Information Technologies | 1986-11-19 |