510(k) clearances

INSPIRA ART100

Inspira Technologies Oxy B.H.N. , Ltd. · Cardiovascular

K232788Substantially EquivalentTraditionalDWA
Open FDA's page for this record
Third party flag
N
City
Ra’Anana
Advisory committee description
Cardiovascular
Address 1
2 Ha-Tidhar St.
Statement or summary
Summary
Product code
DWA
Zip code
4366504
Applicant
Inspira Technologies Oxy B.H.N. , Ltd.
Decision date
2024-05-24
Decision code
SESE
Country code
IL
Device name
INSPIRA ART100
Advisory committee
CV
Contact
Dganit Litinsky
K number
K232788
Date received
2023-09-11
Review advisory committee
CV
Postal code
4366504
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Control, Pump Speed, Cardiopulmonary Bypass
Medical specialty description
Cardiovascular
Regulation number
870.4380
Device class
2
Registration number
2916596, 3015431638, 3014990448, 3019807891, 1220648, 9611109, 3008792657, 3003306248, 3010009632, 1218444, 3010163695, 3021562887, 3006073153, 2184009, 3044156918, 1928237, 1828100, 3004593495, 2029275, 3012119238, 9617601, 2011171
FEI number
2916596, 3015431638, 3014990448, 3019807891, 1220648, 3002808267, 1000306431, 3008792657, 3003306248, 3010009632, 1218444, 3010163695, 1000116158, 3021562887, 3006073153, 3044156918, 1928237, 1828100, 3004593495, 3012119238, 3002534070, 2011171
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.