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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 the device name listed in this FDA 510(k) record. The listed applicant is Resonea, Inc.. It received FDA 510(k) clearance on 2019-07-14 under 510(k) 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. The listed applicant is Resonea, Inc.. The 510(k) number is K173974.

When did DROWZLE receive FDA 510(k) clearance?

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

Who is the listed applicant for DROWZLE?

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

What is the FDA product code for DROWZLE?

The FDA product code for DROWZLE is MNR.

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Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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