AERONOX UNIVERSAL, MODEL P/N 360000, AERONOX BEDSIDE, MODEL P/N 360001, AERONOX TRANSPORT TRANSPORT, MODEL P/N 360002— 510(k) K000653

Name: FDA 510(k) clearance K000653
Creator: U.S. Food and Drug Administration
Published: 2000-08-04

Substantially Equivalent

Pulmonox Medical Corp.

FDA 510(k) clearance K000653 for AERONOX UNIVERSAL, MODEL P/N 360000, AERONOX BEDSIDE, MODEL P/N 360001, AERONOX TRANSPORT TRANSPORT, MODEL P/N 360002, Substantially Equivalent on 2000-08-04. Applicant: Pulmonox Medical Corp.. Device class: 2.

Clearance details

Applicant: Pulmonox Medical Corp.
Product code: Code MRN
Device class: Class 2
Regulation: 21 CFR 868.5165
Advisory panel: Anesthesiology
Date received: 2000-02-28
Decision date: 2000-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tofield, Alberta, CA

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.