INOMAX DS(IR) (DELIVERY SYSTEM)— 510(k) K110635

Name: FDA 510(k) clearance K110635
Creator: U.S. Food and Drug Administration
Published: 2011-06-23

Substantially Equivalent

Ino Therapeutics, LLC/Dba Ikaria

FDA 510(k) clearance K110635 for INOMAX DS(IR) (DELIVERY SYSTEM), Substantially Equivalent on 2011-06-23. Applicant: Ino Therapeutics, LLC/Dba Ikaria. Device class: 2.

Clearance details

Applicant: Ino Therapeutics, LLC/Dba Ikaria
Product code: Code MRN
Device class: Class 2
Regulation: 21 CFR 868.5165
Advisory panel: Anesthesiology
Date received: 2011-03-04
Decision date: 2011-06-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Port Allen, LA, US

Download summary PDF View on FDA.gov ↗

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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.