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FDA 510(k)

DROWZLE

K-Number: K173974 · 2019-07-14

ApplicantResonea, Inc.
Decision Date2019-07-14
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DROWZLE is a medical device manufactured by Resonea, Inc.. It received FDA 510(k) clearance on 2019-07-14 under approval number K173974. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DROWZLE?

DROWZLE is a medical device that received FDA 510(k) clearance on 2019-07-14. It is manufactured by Resonea, Inc.. The 510(k) number is K173974.

When was DROWZLE approved by the FDA?

DROWZLE received FDA 510(k) clearance on 2019-07-14, under approval number K173974.

What company makes DROWZLE?

DROWZLE is manufactured by Resonea, Inc..

What is the FDA product code for DROWZLE?

The FDA product code for DROWZLE is MNR.

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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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