GE DATEX-OHMEDA AISYS
FDA 510(k) clearance K073707 · decided 2008-01-30
Clearance details
- K-number
- K073707
- Device name
- GE DATEX-OHMEDA AISYS
- Applicant
- Datex-Ohmeda, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-12-31
- Decision date
- 2008-01-30
- Days to decision
- 30 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 Aisys, Anesthesia Gas-Machine. recall (Z-1425-2009) | GE Healthcare | 2009-06-23 |
| GE Datex-Ohmeda Aisys, Datex-Ohmeda, Inc., a General Electric Company going to market as G recall (Z-0020-2009) | Datex - Ohmeda, Inc | 2008-10-06 |