510(k) K113549 ยท NHJ Device, Positive Pressure Breathing, Intermittent
COMFORT COUGH
| Applicant | Seoil Pacific Corp., Seoul, KR |
| Decision | Substantially Equivalent, Feb 21, 2013 |
| Received | Dec 1, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113549
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.