Device Classification Name |
Device, Assistive Listening
|
510(k) Number |
K954748 |
Device Name |
POCKETALKER PRO |
Applicant |
WILLIAMS SOUND, LLC |
10300 Valley View Rd |
EDEN PRAIRIE,
MN
55344
|
|
Applicant Contact |
PAUL INGEBRIGTSEN |
Correspondent |
WILLIAMS SOUND, LLC |
10300 Valley View Rd |
EDEN PRAIRIE,
MN
55344
|
|
Correspondent Contact |
PAUL INGEBRIGTSEN |
Regulation Number | 874.3320
|
Classification Product Code |
|
Date Received | 10/16/1995 |
Decision Date | 11/22/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|