GE DATEX-OHMEDA AESPIRE 7900 ANESTHESIA SYSTEM
FDA 510(k) clearance K050626 · decided 2005-03-25
Clearance details
- K-number
- K050626
- Device name
- GE DATEX-OHMEDA AESPIRE 7900 ANESTHESIA SYSTEM
- Applicant
- Datex-Ohmeda, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-03-11
- Decision date
- 2005-03-25
- Days to decision
- 14 days
- Clearance type
- Special
- 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 |
|---|---|---|
| Datex-Ohmeda S/5 Aespire Anesthesia System 7900 recall (Z-0038-06) | Datex-Ohmeda Inc | 2005-10-12 |