Device Classification Name |
Camera, Ophthalmic, Ac-Powered
|
510(k) Number |
K770888 |
Device Name |
POMERANTZEFF EQUATOR PLUS CAMERA |
Applicant |
MEDICAL INSTRUMENT RESEARCH ASSOC., INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
MEDICAL INSTRUMENT RESEARCH ASSOC., INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 886.1120
|
Classification Product Code |
|
Date Received | 05/16/1977 |
Decision Date | 06/03/1977 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|