MARK III OXYGEN WALKER SYS. RESERVOIR— 510(k) K832143

Substantially Equivalent

Linde Div. Union Carbide Corp.

FDA 510(k) clearance K832143 for MARK III OXYGEN WALKER SYS. RESERVOIR, Substantially Equivalent on 1983-08-26. Applicant: Linde Div. Union Carbide Corp..

Clearance details

Applicant: Linde Div. Union Carbide Corp.
Product code: Code BYJ
Advisory panel: Anesthesiology
Date received: 1983-07-05
Decision date: 1983-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.