510(k) K970866 ยท HIF Insufflator, Laparoscopic
FILTER HEATER/HYDRATOR INSUFFLATION GAS CONDITIONER
| Applicant | Georgia Biomedical, Inc., North Attleboro MA, US |
| Decision | Substantially Equivalent, Jan 23, 1998 |
| Received | Mar 10, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970866
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.