Belle Sensilube
K-Number: K230781 · 2023-06-20
ApplicantRb Health (Us), LLC
Decision Date2023-06-20
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Belle Sensilube is a medical device manufactured by Rb Health (Us), LLC. It received FDA 510(k) clearance on 2023-06-20 under approval number K230781. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Belle Sensilube?
Belle Sensilube is a medical device that received FDA 510(k) clearance on 2023-06-20. It is manufactured by Rb Health (Us), LLC. The 510(k) number is K230781.
When was Belle Sensilube approved by the FDA?
Belle Sensilube received FDA 510(k) clearance on 2023-06-20, under approval number K230781.
What company makes Belle Sensilube?
Belle Sensilube is manufactured by Rb Health (Us), LLC.
What is the FDA product code for Belle Sensilube?
The FDA product code for Belle Sensilube is NUC.
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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.