510(k) K943546 ยท BZG Spirometer, Diagnostic
FUKUDA SANGYO MODEL SPIROANALYZER ST-180
| Applicant | Spirosoft Northamerica, Inc., Tustin CA, US |
| Decision | Substantially Equivalent, Feb 23, 1995 |
| Received | Jul 21, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943546
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.