DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS
FDA 510(k) clearance K023366 · decided 2003-10-07
Clearance details
- K-number
- K023366
- Device name
- DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS
- Applicant
- Datex-Ohmeda, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-10-08
- Decision date
- 2003-10-07
- Days to decision
- 364 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, Aestiva 7900, 1006-9305-000. This version of the Datex-Ohmeda 7900 ventilat recall (Z-0678-2016) | GE Medical Systems, LLC | 2016-01-21 |
| GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-Ohmeda Aestiva/ recall (Z-1787-2012) | GE Healthcare, LLC | 2012-06-17 |