GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2)
FDA 510(k) clearance K132530 · decided 2013-12-20
Clearance details
- K-number
- K132530
- Device name
- GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2)
- Applicant
- Datex-Ohmeda, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-08-12
- Decision date
- 2013-12-20
- Days to decision
- 130 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 |
|---|---|---|
| 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 |