meddevicedb.com FDA Device Reference

Analytic for Hemodynamic Instability (AHI)

DEN200022 Class II Direct
Decision Date
2021-03-01
Sponsor / Applicant
Fifth Eye, Inc.

Technical Specification

510(k) Submission ID DEN200022
Product Code QNV
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.2220
Decision Date 2021-03-01
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

Analytic for Hemodynamic Instability (AHI) received FDA 510(k) clearance under submission number DEN200022, sponsored by Fifth Eye, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2021-03-01.

Classification & Regulation

This clearance is catalogued under FDA product code QNV and 21 CFR 870.2220, within the Cardiovascular review panel as a Class II device.