510(k) K081447 ยท BSZ Gas-Machine, Anesthesia
FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO
| Applicant | Draeger Medical AG & Co. KG, Luebeck, DE |
| Decision | Substantially Equivalent, Oct 8, 2008 |
| Received | May 22, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081447
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 24, 2018 | Draeger Medical, Inc. Apollo Anesthesia Machine; Cat. no. 8605310
Product Usage:
Indicated as a continuous flow anesthesia system. The Apollo may be used for manually assisted or automatic ventilation, delivery of gases a Terminated |
BSZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.