The following data is part of a premarket notification filed by Invacare Corporation with the FDA for 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 Conc.
| Device ID | K191159 |
| 510k Number | K191159 |
| Device Name: | 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 Conc |
| Classification | Generator, Oxygen, Portable |
| Applicant | Invacare Corporation One Invacare Way Elyria, OH 44035 |
| Contact | Elijah Wreh |
| Correspondent | Elijah Wreh Invacare Corporation One Invacare Way Elyria, OH 44035 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-01 |
| Decision Date | 2019-08-29 |