Device Classification Name |
Refractometer, Ophthalmic
|
510(k) Number |
K802029 |
Device Name |
OBJECTIVE REFRACTOR |
Applicant |
ZEISS HUMPHREY SYSTEM |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
ZEISS HUMPHREY SYSTEM |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 886.1760
|
Classification Product Code |
|
Date Received | 08/21/1980 |
Decision Date | 11/12/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|