Cleared Special

SureSigns VS3; SureSigns VS4

K163649 · Philips Medical Systems · Cardiovascular
Mar 2017
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K163649 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 Philips Medical Systems (Andover, US). The FDA issued a Cleared decision on March 31, 2017, 98 days after receiving the submission on December 23, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1100.

Submission Details

510(k) Number K163649 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 2016
Decision Date March 31, 2017
Days to Decision 98 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

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