OXYARM CO2
FDA 510(k) clearance K014211 · decided 2002-06-11
Clearance details
- K-number
- K014211
- Device name
- OXYARM CO2
- Applicant
- Southmedic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-12-21
- Decision date
- 2002-06-11
- Days to decision
- 172 days
- Clearance type
- Traditional
- Product code
- CCK
- Device class
- 2
- Regulation number
- 868.1400
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mccordsville, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case. recall (Z-1288-2018) | Southmedic, Inc. | 2018-01-25 |