FDA.report

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

Related Records

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

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