INOMAX DS (DELIVERY SYSTEM), MODEL 10003— 510(k) K080484

Substantially Equivalent

Ino Therapeutics

FDA 510(k) clearance K080484 for INOMAX DS (DELIVERY SYSTEM), MODEL 10003, Substantially Equivalent on 2008-08-06. Applicant: Ino Therapeutics.

Clearance details

Applicant: Ino Therapeutics
Product code: Code MRN
Advisory panel: Anesthesiology
Date received: 2008-02-22
Decision date: 2008-08-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Clinton, NJ, 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.