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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 the device name listed in this FDA 510(k) record. The listed applicant is ShenB Co., Ltd.. It received FDA 510(k) clearance on 2025-03-19 under 510(k) 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. The listed applicant is ShenB Co., Ltd.. The 510(k) number is K242241.

When did Sunny receive FDA 510(k) clearance?

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

Who is the listed applicant for Sunny?

The FDA 510(k) record lists ShenB Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sunny?

The FDA product code for Sunny is GEI.

Other records listing ShenB Co., Ltd. as applicant

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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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