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

Name: FDA 510(k) clearance K983627
Creator: U.S. Food and Drug Administration
Published: 1999-10-22

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.. Device class: 2.

Clearance details

Applicant: Invacare Corp.
Product code: Product code CAW
Device class: Class 2
Regulation: 21 CFR 868.5440
Advisory panel: Anesthesiology
Date received: 1998-10-15
Decision date: 1999-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elyria, OH, US

Download summary PDF View on FDA.gov ↗

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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.