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FDA 510(k)

Reza Band, Reflux Band

K-Number: K173934 · 2018-04-13

ApplicantSomna Therapeutics, LLC
Decision Date2018-04-13
Product CodePKA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Reza Band, Reflux Band is the device name listed in this FDA 510(k) record. The listed applicant is Somna Therapeutics, LLC. It received FDA 510(k) clearance on 2018-04-13 under 510(k) number K173934. The device is classified under product code PKA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reza Band, Reflux Band?

Reza Band, Reflux Band is a medical device that received FDA 510(k) clearance on 2018-04-13. The listed applicant is Somna Therapeutics, LLC. The 510(k) number is K173934.

When did Reza Band, Reflux Band receive FDA 510(k) clearance?

Reza Band, Reflux Band received FDA 510(k) clearance on 2018-04-13, under 510(k) number K173934.

Who is the listed applicant for Reza Band, Reflux Band?

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

What is the FDA product code for Reza Band, Reflux Band?

The FDA product code for Reza Band, Reflux Band is PKA.

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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