Device Classification Name |
Detector And Alarm, Arrhythmia
|
510(k) Number |
K132407 |
Device Name |
VITAL SIGNS PATCH SYSTEM (IN SHORT VSP) |
Applicant |
LIFEWATCH TECHNOLOGIES LTD |
2 PEKERIS STREET |
REHOVOT,
IL
7670202
|
|
Applicant Contact |
ASHER KASSEL |
Correspondent |
LIFEWATCH TECHNOLOGIES LTD |
2 PEKERIS STREET |
REHOVOT,
IL
7670202
|
|
Correspondent Contact |
ASHER KASSEL |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 08/02/2013 |
Decision Date | 12/19/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|