GE DETAX-OHMEDA ANESTHESIA DELIVERY UNIT (ADU)
FDA 510(k) clearance K050676 · decided 2005-04-12
Clearance details
- K-number
- K050676
- Device name
- GE DETAX-OHMEDA ANESTHESIA DELIVERY UNIT (ADU)
- Applicant
- Datex-Ohmeda, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-03-16
- Decision date
- 2005-04-12
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- BSZ
- Device class
- 2
- Regulation number
- 868.5160
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Madison, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GE Datex-Ohmeda ADU Carestation Intended to provide general inhalation anesthesia and vent recall (Z-1633-2009) | GE Healthcare | 2009-07-30 |
| Datex-Ohmeda AS/3 Anesthesia Delivery Unit An Anesthesia Gas Machine for composition of an recall (Z-1634-2009) | GE Healthcare | 2009-07-30 |
| Datex-Ohmeda S/5 Anesthesia Delivery Unit Intended to provide general inhalation anaesthes recall (Z-1635-2009) | GE Healthcare | 2009-07-30 |