Astral 100/150
FDA 510(k) clearance K172875 · decided 2018-04-26
Clearance details
- K-number
- K172875
- Device name
- Astral 100/150
- Applicant
- Resmed, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2017-09-21
- Decision date
- 2018-04-26
- Days to decision
- 217 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Bella Vista, AU
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous recall (Z-2735-2026) | ResMed Ltd. | 2026-07-28 |
| Astral 100 and Astral 150 ventilators recall (Z-0111-2024) | ResMed Ltd. | 2023-10-23 |