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510(k) K221203

Device
AHI System
Applicant
Fifth Eye Inc.
510(k) number
K221203
Product code
QNV  
Decision
Substantially Equivalent (SESE)
Decision date
2022-07-14
Date received
2022-04-26
Regulation
870.2220
Classification name
Adjunctive Hemodynamic Indicator With Decision Point
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jennifer 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
K212219AHI SystemFifth Eye, Inc.2021-12-03
DEN200022Analytic for Hemodynamic Instability (AHI)Fifth Eye, Inc.2021-03-01

Legacy Summary#

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FDA Review#

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