510(k) K003251 ยท BSZ Gas-Machine, Anesthesia
BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690
| Applicant | Blease Medical Equipment , Ltd., Appollo Beach FL, US |
| Decision | Substantially Equivalent, May 23, 2001 |
| Received | Oct 17, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003251
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 20, 2013 | Del Mar Reynolds Medical, Ltd. CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseFocus Anesthesia Workstation with the following part numbers: 12200900; 12200901; 12200902; 12200903; 14200100, Terminated |
BSZ | None listed |
| 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 |
| Dec 19, 2012 | Del Mar Reynolds Medical, Ltd. BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine.
In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. I Terminated |
BSZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.