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FDA 510(k)

V series portable oxygen concentrator (V5, V5C, V6, V6C)

K-Number: K252268 · 2025-12-16

ApplicantShenzhen Harveymed Technology Co., Ltd.
Decision Date2025-12-16
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

V series portable oxygen concentrator (V5, V5C, V6, V6C) is a medical device manufactured by Shenzhen Harveymed Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-12-16 under approval number K252268. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the V series portable oxygen concentrator (V5, V5C, V6, V6C)?

V series portable oxygen concentrator (V5, V5C, V6, V6C) is a medical device that received FDA 510(k) clearance on 2025-12-16. It is manufactured by Shenzhen Harveymed Technology Co., Ltd.. The 510(k) number is K252268.

When was V series portable oxygen concentrator (V5, V5C, V6, V6C) approved by the FDA?

V series portable oxygen concentrator (V5, V5C, V6, V6C) received FDA 510(k) clearance on 2025-12-16, under approval number K252268.

What company makes V series portable oxygen concentrator (V5, V5C, V6, V6C)?

V series portable oxygen concentrator (V5, V5C, V6, V6C) is manufactured by Shenzhen Harveymed Technology Co., Ltd..

What is the FDA product code for V series portable oxygen concentrator (V5, V5C, V6, V6C)?

The FDA product code for V series portable oxygen concentrator (V5, V5C, V6, V6C) is CAW.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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