510(k) K101850 ยท CBK Ventilator, Continuous, Facility Use
SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION
| Applicant | Spacelabs Healthcare, Ltd., Nederland CO, US |
| Decision | Substantially Equivalent, Mar 2, 2011 |
| Received | Jul 1, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101850
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2013 | Del Mar Reynolds Medical, Ltd. Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II Absorber contained in Service Kits Part Number 12200902, 050-0659-00 and 050-0901-00 and any workstation Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.