510(k) K973985 ยท BSZ Gas-Machine, Anesthesia
AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU)
| Applicant | Datex-Engstrom, Inc., Tewksbury MA, US |
| Decision | Substantially Equivalent, Oct 30, 1998 |
| Received | Oct 20, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973985
| 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 |
| Dec 19, 2006 | Datex - Ohmeda, Inc Datex Ohmeda Compact Absorber, Disposable, REF 427002100, white to violet and REF 427002000, Pink to white. Used with GE Healthcare ADU anesthesia systems. GE Healthcare Finland Oy, Helsinki, Finlan Terminated |
BSZ | None listed |
| Jul 12, 2006 | GE Healthcare Fresh Gas Control (A-FGC1) Unit, a component of the S/5 Anesthesia Delivery Unit. The Anesthesia Delivery Unit is designed to mix and dose respiratory gases and to ventilate the patient. The deliver Terminated |
BSZ | None listed |
| May 9, 2006 | GE Healthcare Datex-Ohmeda S/5 Anesthesia Delivery Unit (ADU) Terminated |
BSZ | None listed |
| Jul 20, 2004 | Datex-Ohmeda Inc Datex-Ohmeda S/5 and AS/3 Anesthesia Delivery Units
(The S/5 units are a later version of the AS/3 units. The conversion from AS3 to S5 occurred during the summer of 2000. This change was mainly Terminated |
BSZ | None listed |
| Aug 28, 2003 | Datex-Ohmeda Inc Datex-Ohmeda S/5 Anesthesia Delivery Units Terminated |
BSZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.