INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10— 510(k) K042262

Substantially Equivalent

Sequal Technologies, Inc.

FDA 510(k) clearance K042262 for INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10, Substantially Equivalent on 2004-09-10. Applicant: Sequal Technologies, Inc..

Clearance details

Applicant: Sequal Technologies, Inc.
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 2004-08-23
Decision date: 2004-09-10
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, 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.