510(k) K191875
K191875 is an FDA 510(k) premarket notification submitted by Guangzhou Life Light Electronic Technology Co., Ltd. for the device "Owgels Oxygen Concentrator". The FDA issued a decision of Substantially Equivalent on Jul 20, 2020. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 20, 2020
- Date Received
- Jul 12, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Generator, Oxygen, Portable
- Device Class
- Class II
- Regulation Number
- 868.5440
- Review Panel
- AN
- Submission Type
- 510(k)