SPACELABS ARKON ANESTHESIA WORKSTATION
FDA 510(k) clearance K113051 · decided 2012-03-22
Clearance details
- K-number
- K113051
- Device name
- SPACELABS ARKON ANESTHESIA WORKSTATION
- Applicant
- Spacelabs Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2011-10-13
- Decision date
- 2012-03-22
- Days to decision
- 161 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Nederland, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 6 recall (Z-2589-2018) | Spacelabs Healthcare, Ltd. | 2018-08-10 |
| Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 0 recall (Z-0072-2018) | Spacelabs Healthcare, Ltd. | 2017-11-21 |
| SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This syste recall (Z-1442-2014) | Del Mar Reynolds Medical, Ltd. | 2014-04-12 |
| Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be used recall (Z-1771-2013) | Del Mar Reynolds Medical, Ltd. | 2013-07-19 |