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FDA 510(k)

EVE Synergy (EVE-20M)

K-Number: K241433 · 2025-06-04

ApplicantWeero Co., Ltd.
Decision Date2025-06-04
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

EVE Synergy (EVE-20M) is a medical device manufactured by Weero Co., Ltd.. It received FDA 510(k) clearance on 2025-06-04 under approval number K241433. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVE Synergy (EVE-20M)?

EVE Synergy (EVE-20M) is a medical device that received FDA 510(k) clearance on 2025-06-04. It is manufactured by Weero Co., Ltd.. The 510(k) number is K241433.

When was EVE Synergy (EVE-20M) approved by the FDA?

EVE Synergy (EVE-20M) received FDA 510(k) clearance on 2025-06-04, under approval number K241433.

What company makes EVE Synergy (EVE-20M)?

EVE Synergy (EVE-20M) is manufactured by Weero Co., Ltd..

What is the FDA product code for EVE Synergy (EVE-20M)?

The FDA product code for EVE Synergy (EVE-20M) is IPF.

Other Devices by Weero Co., Ltd.

K240992eMVFit (MVF-10M) K240991eMVFit (MVF-10M) K253261Apollo Quattro (APQ-10M)

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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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