510(k) K964939 ยท BZC Calculator, Pulmonary Function Data
THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUS
| Applicant | Creative Biomedics, Inc., San Clemente CA, US |
| Decision | Substantially Equivalent, Mar 6, 1997 |
| Received | Dec 10, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964939
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.