PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF)— 510(k) K051887

Substantially Equivalent

Carleton Life Support Systems, Inc.

FDA 510(k) clearance K051887 for PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF), Substantially Equivalent on 2005-09-27. Applicant: Carleton Life Support Systems, Inc..

Clearance details

Applicant: Carleton Life Support Systems, Inc.
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 2005-07-12
Decision date: 2005-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Davenport, IA, 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.