MARK III OXYGEN WALKER SYSTEM— 510(k) K820836

Name: FDA 510(k) clearance K820836
Creator: U.S. Food and Drug Administration
Published: 1982-04-15

Substantially Equivalent

Union Carbide Corp.

FDA 510(k) clearance K820836 for MARK III OXYGEN WALKER SYSTEM, Substantially Equivalent on 1982-04-15. Applicant: Union Carbide Corp.. Device class: 2.

Clearance details

Applicant: Union Carbide Corp.
Product code: Code BYJ
Device class: Class 2
Regulation: 21 CFR 868.5655
Advisory panel: Anesthesiology
Date received: 1982-03-26
Decision date: 1982-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K812536 — LINDE MARK II1981-09-23
K810732 — LINDE MARK II OXYGEN RESERV. TYPE OR-41981-03-27
K810596 — CENTRIFI CHEM SYSTEM 400 ANALYZER1981-03-17

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.