510(k) K922428 ยท BZG Spirometer, Diagnostic
FUKUDA DENSHI MODEL SPIROSIFT SP-5000
| Applicant | Fukuda Denshi USA, Inc., Redmond WA, US |
| Decision | Substantially Equivalent, Jan 15, 1993 |
| Received | May 22, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922428
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.