VENTURE IHO 100 HOME FILL COMPLETE HOME OXYGEN SYSTEM— 510(k) K983627

Substantially Equivalent

Invacare Corp.

FDA 510(k) clearance K983627 for VENTURE IHO 100 HOME FILL COMPLETE HOME OXYGEN SYSTEM, Substantially Equivalent on 1999-10-22. Applicant: Invacare Corp..

Clearance details

Applicant: Invacare Corp.
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 1998-10-15
Decision date: 1999-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elyria, OH, 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.