GE DATEX-OHMEDA S/5 ADU CARESTATION
FDA 510(k) clearance K090892 · decided 2009-04-30
Clearance details
- K-number
- K090892
- Device name
- GE DATEX-OHMEDA S/5 ADU CARESTATION
- Applicant
- GE Healthcare Finland Oy
- Decision
- Substantially Equivalent
- Date received
- 2009-03-31
- Decision date
- 2009-04-30
- 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 |
|---|---|---|
| Canister: CO2 canister with GE part numbers 1407-3200-000, 1407-7004-000, or M1084850. Int recall (Z-1443-2013) | GE Healthcare, LLC | 2013-06-03 |