GE DATEX-OHMEDA ENGSTROM CARESTATION
FDA 510(k) clearance K060862 · decided 2006-06-05
Clearance details
- K-number
- K060862
- Device name
- GE DATEX-OHMEDA ENGSTROM CARESTATION
- Applicant
- Datex-Ohmeda, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-03-29
- Decision date
- 2006-06-05
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- 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 Engstrom Carestation Critical Care Ventilator with the High Performance Disp recall (Z-0784-2007) | Datex - Ohmeda, Inc | 2007-05-10 |