NEXT GENERATION PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM— 510(k) K033000

Substantially Equivalent

Essex Cryogenics of Missouri, Inc.

FDA 510(k) clearance K033000 for NEXT GENERATION PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM, Substantially Equivalent on 2004-03-22. Applicant: Essex Cryogenics of Missouri, Inc..

Clearance details

Applicant: Essex Cryogenics of Missouri, Inc.
Product code: Code BYJ
Advisory panel: Anesthesiology
Date received: 2003-09-25
Decision date: 2004-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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Adverse events under product code BYJ

product code BYJ

Death: 16
Total: 16

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.