AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION)— 510(k) K960309

Name: FDA 510(k) clearance K960309
Creator: U.S. Food and Drug Administration
Published: 1997-02-28

Substantially Equivalent

Airsep Corp.

FDA 510(k) clearance K960309 for AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION), Substantially Equivalent on 1997-02-28. Applicant: Airsep Corp.. Device class: 2.

Clearance details

Applicant: Airsep Corp.
Product code: Code CAW
Device class: Class 2
Regulation: 21 CFR 868.5440
Advisory panel: Anesthesiology
Date received: 1996-01-05
Decision date: 1997-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, 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.