Device Classification Name |
Tonometer, Ac-Powered
|
510(k) Number |
K083377 |
Device Name |
ACCUPEN |
Applicant |
ACCUTOME ULTRASOUND, INC. |
263 GREAT VALLEY PARKWAY |
MALVERN,
PA
19355
|
|
Applicant Contact |
BRIAN T.S. BARRETT |
Correspondent |
ACCUTOME ULTRASOUND, INC. |
263 GREAT VALLEY PARKWAY |
MALVERN,
PA
19355
|
|
Correspondent Contact |
BRIAN T.S. BARRETT |
Regulation Number | 886.1930
|
Classification Product Code |
|
Date Received | 11/14/2008 |
Decision Date | 07/27/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|