510(k) K042058 ยท BZG Spirometer, Diagnostic
ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN
| Applicant | Clement Clarke Intl., Ltd., Harlow, GB |
| Decision | Substantially Equivalent, Mar 23, 2005 |
| Received | Jul 30, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042058
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.