510(k) K013812 ยท BZG Spirometer, Diagnostic
SPIROLAB II, MODEL 29
| Applicant | Sdi Diagnostics, Inc., Easton MA, US |
| Decision | Substantially Equivalent, Feb 11, 2002 |
| Received | Nov 15, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013812
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.