510(k) K050676 ยท BSZ Gas-Machine, Anesthesia
GE DETAX-OHMEDA ANESTHESIA DELIVERY UNIT (ADU)
| Applicant | Datex-Ohmeda, Inc., Madison WI, US |
| Decision | Substantially Equivalent, Apr 12, 2005 |
| Received | Mar 16, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050676
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 30, 2009 | GE Healthcare GE Datex-Ohmeda ADU Carestation
Intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. Terminated |
BSZ | None listed |
| Jul 30, 2009 | GE Healthcare Datex-Ohmeda AS/3 Anesthesia Delivery Unit
An Anesthesia Gas Machine for composition of anesthetic breathing gas and manual or mechanical ventilation for patients undergoing anesthesia. Indicated fo Terminated |
BSZ | None listed |
| Jul 30, 2009 | GE Healthcare Datex-Ohmeda S/5 Anesthesia Delivery Unit
Intended to provide general inhalation anaesthesia and ventilatory support to a wide range of patients. Intended for volume or pressure control, pressure su Terminated |
BSZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.