TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR
FDA 510(k) clearance K093881 · decided 2010-03-12
Clearance details
- K-number
- K093881
- Device name
- TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR
- Applicant
- GE Healthcare Finland Oy
- Decision
- Substantially Equivalent
- Date received
- 2009-12-18
- Decision date
- 2010-03-12
- Days to decision
- 84 days
- Clearance type
- Special
- Product code
- DQA
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Helsinki, FI
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter recall (Z-2027-2023) | GE Healthcare Finland Oy | 2023-07-07 |
| TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter recall (Z-2028-2023) | GE Healthcare Finland Oy | 2023-07-07 |
| TruSignal Wrap Sensor, REF TS-W-D; Oximeter recall (Z-2029-2023) | GE Healthcare Finland Oy | 2023-07-07 |
| TruSignal Ear Sensor, REF TS-E-D; Oximeter recall (Z-2030-2023) | GE Healthcare Finland Oy | 2023-07-07 |