Cleared Traditional

Peace N Quiet (0.7.0)

K233435 · Pnq Health · Ear, Nose, Throat
Feb 2024
Decision
137d
Days
Class 2
Risk

About This 510(k) Submission

K233435 is an FDA 510(k) clearance for the Peace N Quiet (0.7.0), a Masker, Tinnitus (Class II — Special Controls, product code KLW), submitted by Pnq Health (Minnetonka, US). The FDA issued a Cleared decision on February 27, 2024, 137 days after receiving the submission on October 13, 2023. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3400.

Submission Details

510(k) Number K233435 FDA.gov
FDA Decision Cleared SESE
Date Received October 13, 2023
Decision Date February 27, 2024
Days to Decision 137 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code KLW — Masker, Tinnitus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3400