meddevicedb.com FDA Device Reference

Acumen Hypotension Prediction Index (HPI) Feature Software

DEN160044 Class II Direct
Decision Date
2018-03-16
Sponsor / Applicant
Edwards Lifesciences, LLC

Technical Specification

510(k) Submission ID DEN160044
Product Code QAQ
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.2210
Decision Date 2018-03-16
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Acumen Hypotension Prediction Index (HPI) Feature Software received FDA 510(k) clearance under submission number DEN160044, sponsored by Edwards Lifesciences, LLC. The device was reviewed via the Direct premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2018-03-16.

Classification & Regulation

This clearance is catalogued under FDA product code QAQ and 21 CFR 870.2210, within the Cardiovascular review panel as a Class II device.