GE DATEX-OHMEDA ENGSTROM CARESTATION
FDA 510(k) clearance K062710 · decided 2006-12-08
Clearance details
- K-number
- K062710
- Device name
- GE DATEX-OHMEDA ENGSTROM CARESTATION
- Applicant
- Datex-Ohmeda, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-09-11
- Decision date
- 2006-12-08
- Days to decision
- 88 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 Datex-Ohmeda Engstrom Carestation The Carestation consists of three main components: a recall (Z-1829-2008) | GE Healthcare | 2008-09-24 |
| GE Datex-Ohmeda Neonatal Enhancement for the Engstrom Carestation, Model # 1505-3272-00, G recall (Z-1526-2008) | Datex - Ohmeda, Inc | 2008-08-16 |