AESPIRE 7900, AESPIRE VIEW
FDA 510(k) clearance K122445 · decided 2012-10-12
Clearance details
- K-number
- K122445
- Device name
- AESPIRE 7900, AESPIRE VIEW
- Applicant
- Datex-Ohmeda
- Decision
- Substantially Equivalent
- Date received
- 2012-08-10
- Decision date
- 2012-10-12
- Days to decision
- 63 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 Healthcare, Aespire 7900, 1009-9012-000 & Aespire View, 1009-9212-000. The family of GE recall (Z-0677-2016) | GE Medical Systems, LLC | 2016-01-21 |
| GE Healthcare, Aespire 7900, Aespire View Anesthesia Machines. Model numbers 1009-9012-000 recall (Z-1376-2015) | GE Healthcare | 2015-04-02 |
| GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for volume recall (Z-0010-2014) | GE Healthcare, LLC | 2013-10-15 |
| 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 |