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FDA 510(k)

KY Banksy Moisture

K-Number: K183505 · 2019-05-17

ApplicantRb Health (Us), LLC
Decision Date2019-05-17
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

KY Banksy Moisture is the device name listed in this FDA 510(k) record. The listed applicant is Rb Health (Us), LLC. It received FDA 510(k) clearance on 2019-05-17 under 510(k) number K183505. 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 KY Banksy Moisture?

KY Banksy Moisture is a medical device that received FDA 510(k) clearance on 2019-05-17. The listed applicant is Rb Health (Us), LLC. The 510(k) number is K183505.

When did KY Banksy Moisture receive FDA 510(k) clearance?

KY Banksy Moisture received FDA 510(k) clearance on 2019-05-17, under 510(k) number K183505.

Who is the listed applicant for KY Banksy Moisture?

The FDA 510(k) record lists Rb Health (Us), LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KY Banksy Moisture?

The FDA product code for KY Banksy Moisture 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.

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