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FDA 510(k)

Sunny

K-Number: K242241 · 2025-03-19

ApplicantShenB Co., Ltd.
Decision Date2025-03-19
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sunny is a medical device manufactured by ShenB Co., Ltd.. It received FDA 510(k) clearance on 2025-03-19 under approval number K242241. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sunny?

Sunny is a medical device that received FDA 510(k) clearance on 2025-03-19. It is manufactured by ShenB Co., Ltd.. The 510(k) number is K242241.

When was Sunny approved by the FDA?

Sunny received FDA 510(k) clearance on 2025-03-19, under approval number K242241.

What company makes Sunny?

Sunny is manufactured by ShenB Co., Ltd..

What is the FDA product code for Sunny?

The FDA product code for Sunny is GEI.

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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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