OXYGEN CONCENTRATOR, MODEL BX-5000— 510(k) K854374

Substantially Equivalent

Healthdyne, Inc.

FDA 510(k) clearance K854374 for OXYGEN CONCENTRATOR, MODEL BX-5000, Substantially Equivalent on 1986-01-03. Applicant: Healthdyne, Inc..

Clearance details

Applicant: Healthdyne, Inc.
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 1985-10-30
Decision date: 1986-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, US

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Adverse events under product code CAW

product code CAW

Death: 204
Injury: 573
Malfunction: 1,400
Other: 6
Total: 2,183

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.