510(k) K010850 ยท LNH System, Nuclear Magnetic Resonance Imaging
POLESTAR N-10
| Applicant | Odin Medical Technologies , Ltd., Yokneam Elit, IL |
| Decision | Substantially Equivalent, Dec 17, 2001 |
| Received | Mar 21, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010850
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.