510(k) K011983 ยท HCC Device, Biofeedback
INSIGHT GENESIS
| Applicant | Fasstech, Burlington MA, US |
| Decision | Substantially Equivalent, Aug 30, 2001 |
| Received | Jun 26, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011983
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.