Oxygen Concentrator
FDA 510(k) clearance K230969 · decided 2023-11-09
Clearance details
- K-number
- K230969
- Device name
- Oxygen Concentrator
- Applicant
- Jiangsu Jumao X-Care Medical Equipment Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-04-05
- Decision date
- 2023-11-09
- Days to decision
- 218 days
- Clearance type
- Traditional
- Product code
- CAW
- Device class
- 2
- Regulation number
- 868.5440
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Danyang, CN
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Jiangsu Jumao X-Care Medical Equipment Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L recall (Z-0795-2025) | JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD | 2025-01-03 |