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 Number | 874.3400
|
Classification Product Code |
|
Date Received | 10/13/2023 |
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
|
|
|