510(k) K965070 ยท QGH Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder
SPECTRUM 5000 Q, 5000Q,M,4000 Q, 4000 M.
| Applicant | Mecta Corp., Lake Oswego OR, US |
| Decision | Substantially Equivalent, Mar 6, 1997 |
| Received | Dec 11, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965070
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.