GE DATEX-OHMEDA AVANCE
FDA 510(k) clearance K081844 · decided 2008-08-29
Clearance details
- K-number
- K081844
- Device name
- GE DATEX-OHMEDA AVANCE
- Applicant
- Datex-Ohmeda, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-06-30
- Decision date
- 2008-08-29
- Days to decision
- 60 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 Avance Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN recall (Z-0009-2011) | GE Healthcare, LLC | 2010-10-06 |
| GE Datex-Ohmeda Amingo Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN recall (Z-0010-2011) | GE Healthcare, LLC | 2010-10-06 |
| GE, 1009-9002-000 Avance Anesthesia Machine and Monitor recall (Z-1527-2010) | Ge Healthcare, Llc | 2010-05-11 |
| GE Datex-Ohmeda Advance Anesthesia Gas-Machine. recall (Z-1426-2009) | GE Healthcare | 2009-06-23 |