510(k) K093525 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITATOR WITH ACE/STATCHE
| Applicant | Ventlab Corp., Mocksville NC, US |
| Decision | Substantially Equivalent, Dec 10, 2009 |
| Received | Nov 16, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K093525
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 1, 2016 | Ventlab LLC STAT-Check Resuscitation Bag
Manual Emergency Resuscitation Bag with Carbon dioxide gas analyzer
Intended for use in various clinical situations to provide respiratory support in the presence of rever Terminated |
CCK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.