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

Ra’Anana, IL

Inspira Technologies Oxy B.H.N. , Ltd. appears in FDA device records in Ra’Anana, IL. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 1 510(k) clearance for Inspira Technologies Oxy B.H.N., Ltd. in 2024.

Clearances by year, as a table
510(k) clearance decisions for Inspira Technologies Oxy B.H.N., Ltd., by decision year
YearClearances
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K232788INSPIRA ART100DWASubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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What MDM checks, and what it does not

MDM coverage

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Data as of , FDA export datePage updated Source: openFDA, public domain