510(k) K132523 ยท JAK System, X-Ray, Tomography, Computed
MYOPERFUSION
| Applicant | Toshibamedical Systems Corporation, Tustin CA, US |
| Decision | Substantially Equivalent, Dec 12, 2013 |
| Received | Aug 12, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132523
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 21, 2014 | GE Healthcare, LLC GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor. Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.