SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION
FDA 510(k) clearance K101850 · decided 2011-03-02
Clearance details
- K-number
- K101850
- Device name
- SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION
- Applicant
- Spacelabs Healthcare, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2010-07-01
- Decision date
- 2011-03-02
- Days to decision
- 244 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 |
|---|---|---|
| Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS recall (Z-0968-2013) | Del Mar Reynolds Medical, Ltd. | 2013-03-20 |