510(k) K210371
K210371 is an FDA 510(k) premarket notification submitted by Qingdao Kingon Medical Science and Technology Co., Ltd. for the device "Portable Oxygen Concentrator, model: P2-E6". The FDA issued a decision of Substantially Equivalent on June 3, 2022. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440. Qingdao Kingon Medical Science and Technology Co., Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 3, 2022
- Date Received
- February 8, 2021
- 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