510(k) K903054 ยท BYD Condenser, Heat And Moisture (Artificial Nose)
HME-10 (TM)
| Applicant | Pharma Systems, Inc., Bernardsville NJ, US |
| Decision | Substantially Equivalent, Oct 31, 1990 |
| Received | Jul 11, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K903054
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 9, 2015 | Arc Medical Inc ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17.
Used as a humidifier in a breathing circuit. Terminated |
BYD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.