INNOSAN TRAVELAIR S PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853— 510(k) K963042

Substantially Equivalent

Sim Italia S.R.L.

FDA 510(k) clearance K963042 for INNOSAN TRAVELAIR S PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853, Substantially Equivalent on 1996-11-01. Applicant: Sim Italia S.R.L..

Clearance details

Applicant: Sim Italia S.R.L.
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 1996-08-05
Decision date: 1996-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck,, NY, 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.