Cleared Traditional

EarlyVue VS30

K190624 · Philips Medizin Systeme Boeblingen GmbH · Cardiovascular
Oct 2019
Decision
230d
Days
Class 2
Risk

About This 510(k) Submission

K190624 is an FDA 510(k) clearance for the EarlyVue VS30, a Alarm, Blood-pressure (Class II — Special Controls, product code DSJ), submitted by Philips Medizin Systeme Boeblingen GmbH (Boeblingen, DE). The FDA issued a Cleared decision on October 27, 2019, 230 days after receiving the submission on March 11, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1100.

Submission Details

510(k) Number K190624 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 2019
Decision Date October 27, 2019
Days to Decision 230 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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