510(k) K973797 ยท CAH Filter, Bacterial, Breathing-Circuit
BREATHING CIRCUIT BACTERIAL FILTER
| Applicant | King Systems Corp., Noblesville IN, US |
| Decision | Substantially Equivalent, Mar 12, 1998 |
| Received | Oct 6, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973797
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 15, 2017 | King Systems Corp. dba Ambu, Inc. UNIVERSAL FLEX2 BREATHING CIRCUIT, Item Numbers: D460-6133Z, D390-6121Z, D390-6121Z, D495-61Z, DF4116-6121Z, D466-61Z, DFP170-6121, DF3115-6121Z, DF375-6121Z, DF3115-6121Z, DF3115-6121Z, D360-8031Z, D Terminated |
CAH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.