VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND MIHM1P
FDA 510(k) clearance K043065 · decided 2005-01-26
Clearance details
- K-number
- K043065
- Device name
- VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND MIHM1P
- Applicant
- Edwards Lifesciences, LLC
- Decision
- Substantially Equivalent
- Date received
- 2004-11-05
- Decision date
- 2005-01-26
- Days to decision
- 82 days
- Clearance type
- Traditional
- Product code
- DRS
- Device class
- 2
- Regulation number
- 870.2850
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| "***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors pressures when a recall (Z-2189-2013) | Edwards Lifesciences, LLC | 2013-09-11 |