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FDA 510(k)

ZQUIET PRO-PLUS

K-Number: K122475 · 2012-12-07

ApplicantSleeping Well, LLC
Decision Date2012-12-07
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZQUIET PRO-PLUS 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 2012-12-07 under 510(k) number K122475. 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 PRO-PLUS?

ZQUIET PRO-PLUS is a medical device that received FDA 510(k) clearance on 2012-12-07. The listed applicant is Sleeping Well, LLC. The 510(k) number is K122475.

When did ZQUIET PRO-PLUS receive FDA 510(k) clearance?

ZQUIET PRO-PLUS received FDA 510(k) clearance on 2012-12-07, under 510(k) number K122475.

Who is the listed applicant for ZQUIET PRO-PLUS?

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 PRO-PLUS?

The FDA product code for ZQUIET PRO-PLUS is LRK.

Related Clinical Trials

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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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 AdvanceK180124ZQuietK093407ZQUIET MOUTHPIECEK090503ZQUIET MOUTHPIECE

Related Devices (Code: LRK)

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.

K262104Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)Ram.Shaw Pte., Ltd.K261912SnØreNegatØrDnB Innovations, LLCK261366VirtusSomnomed, Inc.K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLCK261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.K252942ShaeferHShaeferh, LLC

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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