INNOSAN TRAVELAIR S PLUS PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853 (WITH AC POWER SUPPLY ACCESSORY)— 510(k) K971947

Name: FDA 510(k) clearance K971947
Creator: U.S. Food and Drug Administration
Published: 1997-10-03

Substantially Equivalent

Sim Italia S.R.L.

FDA 510(k) clearance K971947 for INNOSAN TRAVELAIR S PLUS PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853 (WITH AC POWER SUPPLY ACCESSORY), Substantially Equivalent on 1997-10-03. Applicant: Sim Italia S.R.L.. Device class: 2.

Clearance details

Applicant: Sim Italia S.R.L.
Product code: Code CAW
Device class: Class 2
Regulation: 21 CFR 868.5440
Advisory panel: Anesthesiology
Date received: 1997-05-28
Decision date: 1997-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck,, NY, 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.