Device Classification Name |
audiometer
|
510(k) Number |
K914232 |
Device Name |
ASRA, SCREENING AUDIOMETER |
Applicant |
MERCURY ELECTRONICS (SCOT) LTD. |
POLLOK CASTLE ESTATE |
NEWTON MEARNS |
GLASGOW 577 6NU U.K.,
GB
|
|
Applicant Contact |
ERIC W GREIG |
Correspondent |
MERCURY ELECTRONICS (SCOT) LTD. |
POLLOK CASTLE ESTATE |
NEWTON MEARNS |
GLASGOW 577 6NU U.K.,
GB
|
|
Correspondent Contact |
ERIC W GREIG |
Regulation Number | 874.1050
|
Classification Product Code |
|
Date Received | 09/20/1991 |
Decision Date | 01/31/1992 |
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
|
|
|