TROOPER OXYGEN CONCENTRATOR— 510(k) K121260

Substantially Equivalent

Vbox, Inc.

FDA 510(k) clearance K121260 for TROOPER OXYGEN CONCENTRATOR, Substantially Equivalent on 2012-09-21. Applicant: Vbox, Inc..

Clearance details

Applicant: Vbox, Inc.
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 2012-04-26
Decision date: 2012-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: White Bear Lake, MN, 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.