• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Masker, Tinnitus
510(k) Number K233435
Device Name Peace N Quiet (0.7.0)
Applicant
PNQ Health
110 Cheshire Lane
Ste 385
Minnetonka,  MN  55305
Applicant Contact Kurtis Goos
Correspondent
RQM+
2251 San Diego Avenue
Suite B-257
San Diego,  CA  92110
Correspondent Contact Alexia Haralambous
Regulation Number874.3400
Classification Product Code
KLW  
Date Received10/13/2023
Decision Date 02/27/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-