Cleared Traditional

SURESIGNS VS3, SURESIGNS VS4

K133961 · Philips Medical Systems · Cardiovascular
Jun 2014
Decision
184d
Days
Class 2
Risk

About This 510(k) Submission

K133961 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 June 26, 2014, 184 days after receiving the submission on December 24, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1100.

Submission Details

510(k) Number K133961 FDA.gov
FDA Decision Cleared SESE
Date Received December 24, 2013
Decision Date June 26, 2014
Days to Decision 184 days
Submission Type Traditional
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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