The following data is part of a premarket notification filed by Invacare Corporation with the FDA for Invacare Tpoc Portable Concentrator, Model Tpoc100.
| Device ID | K083751 |
| 510k Number | K083751 |
| Device Name: | INVACARE TPOC PORTABLE CONCENTRATOR, MODEL TPOC100 |
| Classification | Generator, Oxygen, Portable |
| Applicant | INVACARE CORPORATION ONE INVACARE WAY PO BOX 4028 Elyria, OH 44036 -2125 |
| Contact | Carroll Martin |
| Correspondent | Carroll Martin INVACARE CORPORATION ONE INVACARE WAY PO BOX 4028 Elyria, OH 44036 -2125 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-17 |
| Decision Date | 2009-05-21 |
| Summary: | summary |