510(k) K946077 ยท BZC Calculator, Pulmonary Function Data
DIRECTIONAL CONTROL VALVES INFLATABLE BALLOON-TYPE AND CONTROLLERS
| Applicant | Hans Rudolph, Inc., Kansas City MO, US |
| Decision | Substantially Equivalent, Sep 15, 1995 |
| Received | Dec 13, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946077
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.