K191159

Substantially Equivalent

Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with Connectivity

Applicant: Invacare Corporation
Product code: CAW
Advisory panel: Anesthesiology
Date received: 2019-05-01
Decision date: 2019-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elyria, OH, US

Download summary PDF View on FDA.gov ↗

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.