FDA.reportPublic FDA data

510(k) K212219

Device
AHI System
Applicant
Fifth Eye Inc.
510(k) number
K212219
Product code
QNV  
Decision
Substantially Equivalent (SESE)
Decision date
2021-12-03
Date received
2021-07-16
Regulation
870.2220
Classification name
Adjunctive Hemodynamic Indicator With Decision Point
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jennifer A. Baird
Address
110 Miller Ave., Suite 300 Ann Arbor MI US 48104 48104

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QNV  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K221203AHI SystemFifth Eye, Inc.2022-07-14
DEN200022Analytic for Hemodynamic Instability (AHI)Fifth Eye, Inc.2021-03-01

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases