Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
|
510(k) Number |
K113264 |
Device Name |
ELECTRO SENSOR COMPLEX SOFTWARE (ES COMPLEX SOFTWARE) |
Applicant |
LD TECHNOLOGY LLC |
100 Biscayne Blvd Ste 502 |
Miami,
FL
33132
|
|
Applicant Contact |
ABBERT MAAREK |
Correspondent |
LD TECHNOLOGY LLC |
100 Biscayne Blvd Ste 502 |
Miami,
FL
33132
|
|
Correspondent Contact |
ABBERT MAAREK |
Regulation Number | 870.1130
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/04/2011 |
Decision Date | 03/02/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|