510(k) K252268
K252268 is an FDA 510(k) premarket notification submitted by Shenzhen Harveymed Technology Co., Ltd. for the device "V series portable oxygen concentrator (V5, V5C, V6, V6C)". The FDA issued a decision of Substantially Equivalent on December 16, 2025. 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
- December 16, 2025
- Date Received
- July 21, 2025
- 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