Device Classification Name |
Ophthalmoscope, Battery-Powered
|
510(k) Number |
K873987 |
Device Name |
IRAS GLARE TESTER |
Applicant |
RANDWAL INSTRUMENT CO., INC. |
278 WORCESTER ST. |
SOUTHBRIDGE,
MA
01550
|
|
Applicant Contact |
CYR |
Correspondent |
RANDWAL INSTRUMENT CO., INC. |
278 WORCESTER ST. |
SOUTHBRIDGE,
MA
01550
|
|
Correspondent Contact |
CYR |
Regulation Number | 886.1570
|
Classification Product Code |
|
Date Received | 09/29/1987 |
Decision Date | 11/24/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|