Personalized Physiology Analytics Engine software— 510(k) K142512

Name: FDA 510(k) clearance K142512
Creator: U.S. Food and Drug Administration
Published: 2015-06-11

Substantially Equivalent

Vgbio, Inc (Dba Physiq)

FDA 510(k) clearance K142512 for Personalized Physiology Analytics Engine software, Substantially Equivalent on 2015-06-11. Applicant: Vgbio, Inc (Dba Physiq). Device class: 2.

Clearance details

Applicant: Vgbio, Inc (Dba Physiq)
Product code: Code PLB
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2014-09-08
Decision date: 2015-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naperville, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.