INSPIRA ART100— 510(k) K232788
Substantially EquivalentInspira Technologies Oxy B.H.N. , Ltd.
FDA 510(k) clearance K232788 for INSPIRA ART100, Substantially Equivalent on 2024-05-24. Applicant: Inspira Technologies Oxy B.H.N. , Ltd.. Device class: 2.
Clearance details
- Applicant
- Inspira Technologies Oxy B.H.N. , Ltd.
- Product code
- Code DWA
- Device class
- Class 2
- Regulation
- 21 CFR 870.4380
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- RaAnana, IL
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Adverse events under product code DWA
product code DWA- Death
- 15
- Malfunction
- 1,654
- Total
- 1,669
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.