DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR
FDA 510(k) clearance K000706 · decided 2000-05-11
Clearance details
- K-number
- K000706
- Device name
- DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR
- Applicant
- Datex-Ohmeda, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-03-02
- Decision date
- 2000-05-11
- Days to decision
- 70 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 7100 recall (Z-0037-06) | Datex-Ohmeda Inc | 2005-10-12 |
| Datex-Ohmeda Aestiva/5 Active Gas Scavenging System, used with a Model 7100 Ventillator, o recall (Z-0968-04) | Datex-Ohmeda Inc | 2004-07-20 |