510(k) K122932 ยท JOH Tube Tracheostomy And Tube Cuff
SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT
| Applicant | Fogless International AB, Vaggeryd, SE |
| Decision | Substantially Equivalent, Dec 23, 2013 |
| Received | Sep 24, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122932
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.