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FDA 510(k)

Peace N Quiet (0.7.0)

K-Number: K233435 · 2024-02-27

ApplicantPnq Health
Decision Date2024-02-27
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Peace N Quiet (0.7.0) is the device name listed in this FDA 510(k) record. The listed applicant is Pnq Health. It received FDA 510(k) clearance on 2024-02-27 under 510(k) number K233435. The device is classified under product code KLW. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Peace N Quiet (0.7.0)?

Peace N Quiet (0.7.0) is a medical device that received FDA 510(k) clearance on 2024-02-27. The listed applicant is Pnq Health. The 510(k) number is K233435.

When did Peace N Quiet (0.7.0) receive FDA 510(k) clearance?

Peace N Quiet (0.7.0) received FDA 510(k) clearance on 2024-02-27, under 510(k) number K233435.

Who is the listed applicant for Peace N Quiet (0.7.0)?

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

What is the FDA product code for Peace N Quiet (0.7.0)?

The FDA product code for Peace N Quiet (0.7.0) is KLW.

Related Devices (Code: KLW)

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.

K260413Levo Gen 2 Tinnitus Therapy SystemLevo Medical CorporationK260614Tinnitus TherapySivantos GmbHK223694Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)Duearity ABK221168Tinnitogram Signal GeneratorGoldenear Company, Inc.K221125SilentCloudAureliym GmbHK201370Multiflex Tinnitus TechnologyStarkey Laboratories, Inc.

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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