Home / 510(k) Clearances / K142512

510(k) K142512

Personalized Physiology Analytics Engine software by Vgbio, Inc (Dba Physiq) — Product Code PLB

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 11, 2015
Date Received: September 8, 2014
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Multivariate Vital Signs Index
Device Class: Class II
Regulation Number: 870.2300
Review Panel: CV
Submission Type

Automated calculation of a summary index (or indices) based on several individual measured vital sign inputs.