Device Classification Name |
Calibrator, Hearing Aid / Earphone And Analysis Systems
|
510(k) Number |
K050496 |
Device Name |
REM440 |
Applicant |
INTERACOUSTICS A/S, ASSENS |
9675 WEST 76TH ST. |
EDEN PRAIRIE,
MN
55344
|
|
Applicant Contact |
DANIEL EGGAN |
Correspondent |
INTERACOUSTICS A/S, ASSENS |
9675 WEST 76TH ST. |
EDEN PRAIRIE,
MN
55344
|
|
Correspondent Contact |
DANIEL EGGAN |
Regulation Number | 874.3310
|
Classification Product Code |
|
Date Received | 02/28/2005 |
Decision Date | 04/29/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|