510(k) K801087 ยท BZO Set, Tubing And Support, Ventilator (W Harness)
NEONATAL BREATHING CIRCUIT SYSTEM
| Applicant | Isothermal Systems, Inc., Walker MI, US |
| Decision | Substantially Equivalent, May 23, 1980 |
| Received | May 7, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801087
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.