510(k) K970840 ยท BZC Calculator, Pulmonary Function Data
INTELLIFLOW RESPIRATORY ANALYZER
| Applicant | Simtec, Inc., Marion SC, US |
| Decision | Substantially Equivalent, Nov 26, 1997 |
| Received | Mar 7, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970840
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.