Device Classification Name |
Ophthalmoscope, Ac-Powered
|
510(k) Number |
K881984 |
Device Name |
EOL, MODEL LIO |
Applicant |
EOL, INC. |
701 SCARBORO RD. |
OAK RIDGE,
TN
37830
|
|
Applicant Contact |
ROGER LEACH |
Correspondent |
EOL, INC. |
701 SCARBORO RD. |
OAK RIDGE,
TN
37830
|
|
Correspondent Contact |
ROGER LEACH |
Regulation Number | 886.1570
|
Classification Product Code |
|
Date Received | 05/12/1988 |
Decision Date | 09/06/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|