Cleared Special

SureSigns VS3, SureSigns VS4

K151761 · Phillips Medical Systems · Cardiovascular
Sep 2015
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K151761 is an FDA 510(k) clearance for the SureSigns VS3, SureSigns VS4, a Alarm, Blood-pressure (Class II — Special Controls, product code DSJ), submitted by Phillips Medical Systems (Andover, US). The FDA issued a Cleared decision on September 29, 2015, 92 days after receiving the submission on June 29, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1100.

Submission Details

510(k) Number K151761 FDA.gov
FDA Decision Cleared SESE
Date Received June 29, 2015
Decision Date September 29, 2015
Days to Decision 92 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSJ — Alarm, Blood-pressure
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1100