Device Classification Name |
Refractometer, Ophthalmic
|
510(k) Number |
K802958 |
Device Name |
AUTO REFRACTOMETER NR-1000 |
Applicant |
NIPPON KOGAKU, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
NIPPON KOGAKU, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 886.1760
|
Classification Product Code |
|
Date Received | 11/20/1980 |
Decision Date | 04/23/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|