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510(k) K252268

V series portable oxygen concentrator (V5, V5C, V6, V6C) by Shenzhen Harveymed Technology Co., Ltd. — Product Code CAW

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

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