510(k) K132407

VITAL SIGNS PATCH SYSTEM (IN SHORT VSP) by Lifewatch Technologies , Ltd. — Product Code DSI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2014
Date Received
August 2, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector And Alarm, Arrhythmia
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type