HOME-AWAY SYSTEM, MODEL 1041— 510(k) K042944

Substantially Equivalent

In-X Corporation

FDA 510(k) clearance K042944 for HOME-AWAY SYSTEM, MODEL 1041, Substantially Equivalent on 2005-04-15. Applicant: In-X Corporation.

Clearance details

Applicant: In-X Corporation
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 2004-10-25
Decision date: 2005-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denver, CO, US

Download summary PDF View on FDA.gov ↗

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.