OXYGEN CONCENTRATOR W/CONCENTRATION 3LPM 93% +/-3%— 510(k) K884563

Substantially Equivalent

Ivex Medical, Inc.

FDA 510(k) clearance K884563 for OXYGEN CONCENTRATOR W/CONCENTRATION 3LPM 93% +/-3%, Substantially Equivalent on 1989-04-26. Applicant: Ivex Medical, Inc..

Clearance details

Applicant: Ivex Medical, Inc.
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 1988-10-31
Decision date: 1989-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, 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.