Sunny Plus (Sunny)
K-Number: K251649 · 2025-09-18
ApplicantShenB Co., Ltd.
Decision Date2025-09-18
Product CodeNFO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Sunny Plus (Sunny) is a medical device manufactured by ShenB Co., Ltd.. It received FDA 510(k) clearance on 2025-09-18 under approval number K251649. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sunny Plus (Sunny)?
Sunny Plus (Sunny) is a medical device that received FDA 510(k) clearance on 2025-09-18. It is manufactured by ShenB Co., Ltd.. The 510(k) number is K251649.
When was Sunny Plus (Sunny) approved by the FDA?
Sunny Plus (Sunny) received FDA 510(k) clearance on 2025-09-18, under approval number K251649.
What company makes Sunny Plus (Sunny)?
Sunny Plus (Sunny) is manufactured by ShenB Co., Ltd..
What is the FDA product code for Sunny Plus (Sunny)?
The FDA product code for Sunny Plus (Sunny) is NFO.
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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.