TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES
FDA 510(k) clearance K021955 · decided 2002-10-08
Clearance details
- K-number
- K021955
- Device name
- TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES
- Applicant
- Datex-Ohmeda, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-06-14
- Decision date
- 2002-10-08
- Days to decision
- 116 days
- Clearance type
- Special
- Product code
- DQA
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Louisville, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; Oximeter recall (Z-2033-2023) | GE Healthcare Finland Oy | 2023-07-07 |
| TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter recall (Z-2034-2023) | GE Healthcare Finland Oy | 2023-07-07 |