Last synced on 20 May 2022 at 11:05 pm

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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191159
510(k) Type
Traditional
Applicant
Invacare Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/29/2019
Days to Decision
120 days
Submission Type
Summary

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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191159
510(k) Type
Traditional
Applicant
Invacare Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/29/2019
Days to Decision
120 days
Submission Type
Summary