Device Classification Name |
keratoscope, ac-powered
|
510(k) Number |
K781994 |
Device Name |
AUTOKERATOMETER, INSTRUMENT |
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 | 886.1350
|
Classification Product Code |
|
Date Received | 11/29/1978 |
Decision Date | 02/12/1979 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|