Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
|
510(k) Number |
K151869 |
Device Name |
Microlife Upper Arm Automatic Digital Blood Pressure Monitor |
Applicant |
MICROLIFE INTELLECTUAL PROPERTY GMBH, SWITZERLAND |
ESPENSTRASSE 139 |
WIDNAU,
CH
9443
|
|
Applicant Contact |
GERHARD FRICK |
Correspondent |
MDI CONSULTANTS, INC. |
55 NORTHERN BLVD., SUITE 200 |
GREAT NECK,
NY
11021
|
|
Correspondent Contact |
SUSAN D. GOLDSTEIN-FALK |
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 07/09/2015 |
Decision Date | 09/02/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|