510(k) K222920

Oxygen concentrator by Zhengzhou Olive Electronic Technology Co., Ltd. — Product Code CAW

K222920 is an FDA 510(k) premarket notification submitted by Zhengzhou Olive Electronic Technology Co., Ltd. for the device "Oxygen concentrator". The FDA issued a decision of Substantially Equivalent on July 20, 2023. 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
July 20, 2023
Date Received
September 26, 2022
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