510(k) K983550 ยท HCC Device, Biofeedback
XYZ SYSTEM
| Applicant | Bio-Monitoring International Corp., Great Neck NY, US |
| Decision | Substantially Equivalent, Jan 7, 1999 |
| Received | Oct 9, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983550
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.