Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K944986 |
Device Name |
EMSEE LABS MODEL C |
Applicant |
EMSEE LAB OF FLORIDA |
36141 US 19 N |
PALM HARBOR,
FL
34684
|
|
Applicant Contact |
HARVEY L ROMANEK |
Correspondent |
EMSEE LAB OF FLORIDA |
36141 US 19 N |
PALM HARBOR,
FL
34684
|
|
Correspondent Contact |
HARVEY L ROMANEK |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 10/12/1994 |
Decision Date | 12/30/1994 |
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
|
|
|