DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSORIES (WITH TRUTRAK+MOTION CORRECTION PERFORMANCE
FDA 510(k) clearance K011670 · decided 2001-06-26
Clearance details
- K-number
- K011670
- Device name
- DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSORIES (WITH TRUTRAK+MOTION CORRECTION PERFORMANCE
- Applicant
- Datex-Ohmeda
- Decision
- Substantially Equivalent
- Date received
- 2001-05-30
- Decision date
- 2001-06-26
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- DQA
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Tewksbury, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Datex-Ohmeda S/5 Oxygen Saturation Module (M-OSAT) recall (Z-0610-03) | Datex-Ohmeda | 2003-03-05 |