Device Classification Name |
system, measurement, blood-pressure, non-invasive
|
510(k) Number |
K200738 |
Device Name |
Microlife Upper Arm Automatic Digital Blood Pressure Monitor |
Applicant |
Microlife Intellectual Property GmbH |
Espenstrasse 139 |
Widnau,
CH
9443
|
|
Applicant Contact |
Gerhard Frick |
Correspondent |
mdi Consultants, Inc. |
55 Northern Blvd, Suite 200 |
Great Neck,
NY
11021
|
|
Correspondent Contact |
Vaibhav Arvind Rajal |
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 03/23/2020 |
Decision Date | 07/23/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|