Cleared Traditional

Personalized Physiology Analytics Engine software

K142512 · Vgbio, Inc (Dba Physiq) · Cardiovascular
Jun 2015
Decision
276d
Days
Class 2
Risk

About This 510(k) Submission

K142512 is an FDA 510(k) clearance for the Personalized Physiology Analytics Engine software, a Multivariate Vital Signs Index (Class II — Special Controls, product code PLB), submitted by Vgbio, Inc (Dba Physiq) (Naperville, US). The FDA issued a Cleared decision on June 11, 2015, 276 days after receiving the submission on September 8, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number K142512 FDA.gov
FDA Decision Cleared SESE
Date Received September 08, 2014
Decision Date June 11, 2015
Days to Decision 276 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code PLB — Multivariate Vital Signs Index
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2300
Definition Automated Calculation Of A Summary Index (or Indices) Based On Several Individual Measured Vital Sign Inputs.