Device Classification Name |
System, Imaging, Pulsed Echo, Ultrasonic
|
510(k) Number |
K121243 |
Device Name |
ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER |
Applicant |
MEDA CO. LTD. |
13505 BROADFIELD DR. |
POTOMAC,
MD
20854
|
|
Applicant Contact |
KAI CHEN |
Correspondent |
MEDA CO. LTD. |
13505 BROADFIELD DR. |
POTOMAC,
MD
20854
|
|
Correspondent Contact |
KAI CHEN |
Regulation Number | 892.1560
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/25/2012 |
Decision Date | 05/03/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|