FDA.reportPublic FDA data

510(k) K232788

Device
INSPIRA ART100
Applicant
Inspira Technologies Oxy B.H.N. , Ltd.
510(k) number
K232788
Product code
DWA
Decision
Substantially Equivalent (SESE)
Decision date
2024-05-24
Date received
2023-09-11
Regulation
870.4380
Classification name
Control, Pump Speed, Cardiopulmonary Bypass
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Dganit Litinsky
Address
2 Ha-Tidhar St. Ra’Anana IL 4366504 4366504

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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