510(k) K980878 ยท BZM Calculator, Pulmonary Function Interpretor (Diagnostic)
PULMOTRACK,MODEL 1010
| Applicant | Karmel Medical Acoustic Technologies , Ltd., Tirat Hacarmel, IL |
| Decision | Substantially Equivalent, Dec 28, 1998 |
| Received | Mar 9, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980878
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.