GE DATEX-OHMEDA AISYS
FDA 510(k) clearance K110213 · decided 2011-07-20
Clearance details
- K-number
- K110213
- Device name
- GE DATEX-OHMEDA AISYS
- Applicant
- Datex-Ohmeda, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-01-25
- Decision date
- 2011-07-20
- Days to decision
- 176 days
- Clearance type
- Traditional
- 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 |
|---|---|---|
| Aisys Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X recall (Z-0411-2019) | GE Healthcare, LLC | 2018-11-09 |
| Aisys CS2 Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO recall (Z-0412-2019) | GE Healthcare, LLC | 2018-11-09 |
| Touchscreen display kit. Sold under the following product names: TOUCHSCREEN DISPLAY KIT 1 recall (Z-0413-2019) | GE Healthcare, LLC | 2018-11-09 |
| GE Healthcare, Aisys, 1011-9000-000. The GE Datex-Ohmeda Aisys Anesthesia System is intend recall (Z-0680-2016) | GE Medical Systems, LLC | 2016-01-21 |
| GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure cont recall (Z-0009-2014) | GE Healthcare, LLC | 2013-10-15 |
| 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 |