Device Classification Name |
instrument, measuring, lens, ac-powered
|
510(k) Number |
K782096 |
Device Name |
INSTRUMENTS, OVERREFRACTION SYSTEM |
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 | 886.1425
|
Classification Product Code |
|
Date Received | 12/18/1978 |
Decision Date | 01/26/1979 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|