Owgels Oxygen Concentrator
FDA 510(k) clearance K191875 · decided 2020-07-20
Clearance details
- K-number
- K191875
- Device name
- Owgels Oxygen Concentrator
- Applicant
- Guangzhou Life Light Electronic Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2019-07-12
- Decision date
- 2020-07-20
- Days to decision
- 374 days
- Clearance type
- Traditional
- Product code
- CAW
- Device class
- 2
- Regulation number
- 868.5440
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Guangzhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.