BACKPACK MEDICAL OXYGEN SYSTEM— 510(k) K071581

Name: FDA 510(k) clearance K071581
Creator: U.S. Food and Drug Administration
Published: 2007-07-11

Substantially Equivalent

Essex Cryogenics of Missouri, Inc.

FDA 510(k) clearance K071581 for BACKPACK MEDICAL OXYGEN SYSTEM, Substantially Equivalent on 2007-07-11. Applicant: Essex Cryogenics of Missouri, Inc.. Device class: 2.

Clearance details

Applicant: Essex Cryogenics of Missouri, Inc.
Product code: Code BYJ
Device class: Class 2
Regulation: 21 CFR 868.5655
Advisory panel: Anesthesiology
Date received: 2007-06-08
Decision date: 2007-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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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.