Device Classification Name |
Tonometer, Ac-Powered
|
510(k) Number |
K873422 |
Device Name |
OBF MODEL 115 COMPUTER TONOMETER SYSTEM |
Applicant |
OCULAR BLOOD FLOW LABORATORIES, INC. |
9 CANDLELIGHT COURT |
TIMONIUM,
MD
21093
|
|
Applicant Contact |
KENT C HOFFMAN |
Correspondent |
OCULAR BLOOD FLOW LABORATORIES, INC. |
9 CANDLELIGHT COURT |
TIMONIUM,
MD
21093
|
|
Correspondent Contact |
KENT C HOFFMAN |
Regulation Number | 886.1930
|
Classification Product Code |
|
Date Received | 08/26/1987 |
Decision Date | 11/02/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|