Device Classification Name |
calibrator, hearing aid / earphone and analysis systems
|
510(k) Number |
K862086 |
Device Name |
IN SITU EAR GAIN AUDIO TEST STAT TYPE 2118/WH 1823 |
Applicant |
A/S BRUEL & KJAER |
18, NAERUM HOVEDGADE |
DK-2850 NAERUM |
DENMARK,
DK
|
|
Applicant Contact |
AAGE RUBY |
Correspondent |
A/S BRUEL & KJAER |
18, NAERUM HOVEDGADE |
DK-2850 NAERUM |
DENMARK,
DK
|
|
Correspondent Contact |
AAGE RUBY |
Regulation Number | 874.3310
|
Classification Product Code |
|
Date Received | 06/02/1986 |
Decision Date | 07/16/1986 |
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
|
|
|