510(k) K051279 ยท BZK Spirometer, Monitoring (W/Wo Alarm)
CALDYNE, INC. EXHALOMETER EX100, MODEL EX100
| Applicant | Caldyne, Inc., Temecula CA, US |
| Decision | Substantially Equivalent, Sep 7, 2005 |
| Received | May 17, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051279
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.