OMNI OXYGEN SYSTEM, MODEL 1000
FDA 510(k) clearance K013931 · decided 2002-03-27
Clearance details
- K-number
- K013931
- Device name
- OMNI OXYGEN SYSTEM, MODEL 1000
- Applicant
- Sequal Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-11-28
- Decision date
- 2002-03-27
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- CAW
- Device class
- 2
- Regulation number
- 868.5440
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SeQual Technologies Inc. Eclipse Oxygen System, Model 1000 Indicated for the administratio recall (Z-0567-2010) | Sequal Technologies Inc | 2009-12-23 |