510(k) K874746 ยท BSJ Mask, Gas, Anesthetic
SEALFLEX MASK
| Applicant | Engineered Medical Systems, Indianapolis IN, US |
| Decision | Substantially Equivalent, Dec 21, 1987 |
| Received | Nov 18, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K874746
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 10, 2013 | Engineered Medical Systems,Inc Respironics SealFlex Single Port Ribbed Mask (Infant).
For general use in respiratory and anesthesia applications as a conduit for various gases to resuscitate or to enhance breathing abilities of th Terminated |
BSJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.