FDA 510(k)

ZQuiet

K-Number: K180124 · 2018-06-12

Decision Date2018-06-12

Product CodeLRK

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

ZQuiet is the device name listed in this FDA 510(k) record. The listed applicant is Sleeping Well, LLC. It received FDA 510(k) clearance on 2018-06-12 under 510(k) number K180124. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZQuiet?

ZQuiet is a medical device that received FDA 510(k) clearance on 2018-06-12. The listed applicant is Sleeping Well, LLC. The 510(k) number is K180124.

When did ZQuiet receive FDA 510(k) clearance?

ZQuiet received FDA 510(k) clearance on 2018-06-12, under 510(k) number K180124.

Who is the listed applicant for ZQuiet?

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

What is the FDA product code for ZQuiet?

The FDA product code for ZQuiet is LRK.

Other records listing Sleeping Well, LLC as applicant

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.

K213088ZQuiet Advance

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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.