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FDA 510(k)

WERAY

K-Number: K241963 · 2024-07-30

ApplicantPicopack Co., Ltd.
Decision Date2024-07-30
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

WERAY is a medical device manufactured by Picopack Co., Ltd.. It received FDA 510(k) clearance on 2024-07-30 under approval number K241963. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WERAY?

WERAY is a medical device that received FDA 510(k) clearance on 2024-07-30. It is manufactured by Picopack Co., Ltd.. The 510(k) number is K241963.

When was WERAY approved by the FDA?

WERAY received FDA 510(k) clearance on 2024-07-30, under approval number K241963.

What company makes WERAY?

WERAY is manufactured by Picopack Co., Ltd..

What is the FDA product code for WERAY?

The FDA product code for WERAY is EHD.

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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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