510(k) K993410 ยท BSZ Gas-Machine, Anesthesia
DATES-OHMEDA AESTIVA SMARTVENT MRI
| Applicant | Datex-Ohmeda, Inc., Madison WI, US |
| Decision | Substantially Equivalent, Apr 25, 2000 |
| Received | Oct 12, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993410
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Datex-Ohmeda Inc Datex-Ohmeda Aestiva/5 Active Gas Scavenging System, Part Number 1406-8216-000, used with a Model 7900 Ventillator, on a Aestiva/5 Anesthesia Machine, in a Magnetic Reasonance Suite. Terminated |
CBN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.