GE DATEX-OHMEDA AVANCE
FDA 510(k) clearance K112722 · decided 2011-12-16
Clearance details
- K-number
- K112722
- Device name
- GE DATEX-OHMEDA AVANCE
- Applicant
- Datex-Ohmeda, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-09-19
- Decision date
- 2011-12-16
- Days to decision
- 88 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
+ Add to Predicate Builder ◉ Watch Datex-Ohmeda
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GE Healthcare, Aisys CS2,1011-9050-000; Avance Amingo,1009-9002-000, & Avance CS2, 1009-90 recall (Z-0681-2016) | 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 |