INOmax DSIR Plus MRI— 510(k) K143213

Substantially Equivalent

Ino Therapeutics/Ikaria

FDA 510(k) clearance K143213 for INOmax DSIR Plus MRI, Substantially Equivalent on 2015-07-10. Applicant: Ino Therapeutics/Ikaria.

Clearance details

Applicant: Ino Therapeutics/Ikaria
Product code: Code MRN
Advisory panel: Anesthesiology
Date received: 2014-11-10
Decision date: 2015-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madison, WI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MRN

product code MRN

Death: 9
Malfunction: 910
Total: 919

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.