510(k) K011516 ยท BZD Ventilator, Non-Continuous (Respirator)
INFANT FLOW SYSTEM, MODEL M672P
| Applicant | Eme (Electro Medical Equipment) , Ltd., Brighton, Sussex, GB |
| Decision | Substantially Equivalent, Jun 8, 2001 |
| Received | May 17, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011516
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.