Aisys CS2
FDA 510(k) clearance K170872 · decided 2017-08-15
Clearance details
- K-number
- K170872
- Device name
- Aisys CS2
- Applicant
- Datex-Ohmeda, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-03-23
- Decision date
- 2017-08-15
- Days to decision
- 145 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 |