FDA.reportPublic FDA data

510(k) K233435

Device
Peace N Quiet (0.7.0)
Applicant
Pnq Health
510(k) number
K233435
Product code
KLW
Decision
Substantially Equivalent (SESE)
Decision date
2024-02-27
Date received
2023-10-13
Regulation
874.3400
Classification name
Masker, Tinnitus
Medical specialty
Ear, Nose, Throat
Review panel
Ear, Nose, Throat
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Kurtis Goos
Address
110 Cheshire Ln. Suite 385 Minnetonka MN US 55305 55305

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KLW#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K223694Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)Duearity AB2023-06-30
K221168Tinnitogram Signal GeneratorGoldenear Company, Inc.2023-02-01
K221125SilentCloudAureliym GmbH2023-01-04
K201370Multiflex Tinnitus TechnologyStarkey Laboratories, Inc.2020-06-19
K193303Tinnitus Sound Generator ModuleGN Hearing A/S2020-02-20
K180495Tinnitus Sound Generator ModuleGN Hearing A/S2018-11-30
K181586Tinnitus Sound Generator ModuleGN Hearing A/S2018-07-13
K171243audifon Tinnitus-ModuleAudiofon USA, Inc.2017-10-19
K163094TinniLogic Mobile Tinnitus Management DeviceJiangsu Betterlife Medical Co., Ltd.2017-05-17
K161562Sound Options Tinnitus TreatmentSound Options Tinnitus Treatments, Inc.2016-09-28
K161331HyperSound Tinnitus ModuleTurtle Beach Corporation2016-08-23
K151558Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro SystemNeurotherapies Reset GmbH2016-01-20
K151719REVE134Kw Ear Lab, Inc.2015-10-09
K150014SerenitySanuthera, Inc.2015-07-27
K150171Tinnitus Sound Generator ModuleGn Resound A/S2015-05-14