Device Classification Name |
Ophthalmoscope, Battery-Powered
|
510(k) Number |
K950796 |
Device Name |
HALOGEN DIAGNOSTIC SET BX A - 12345 |
Applicant |
NEITZ INSTRUMENTS COMPANY, LTD. |
36-13, WAKAMATSU-CHO, |
SHINJUKU-KU |
TOKYO,
JP
162-0056
|
|
Applicant Contact |
YASUO KAWANO |
Correspondent |
NEITZ INSTRUMENTS COMPANY, LTD. |
36-13, WAKAMATSU-CHO, |
SHINJUKU-KU |
TOKYO,
JP
162-0056
|
|
Correspondent Contact |
YASUO KAWANO |
Regulation Number | 886.1570
|
Classification Product Code |
|
Date Received | 02/21/1995 |
Decision Date | 03/22/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|