ASTRAL VENTILATOR
FDA 510(k) clearance K133868 · decided 2014-06-04
Clearance details
- K-number
- K133868
- Device name
- ASTRAL VENTILATOR
- Applicant
- Resmed, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2013-12-20
- Decision date
- 2014-06-04
- Days to decision
- 166 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily used as non-in recall (Z-0746-2016) | Resmed Corporation | 2016-02-03 |
| Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator. recall (Z-1750-2015) | ResMed Ltd. | 2015-06-10 |