The following data is part of a premarket notification filed by Invacare Corp. with the FDA for The Invacare Flyer, Model Ipc 100.
| Device ID | K071928 |
| 510k Number | K071928 |
| Device Name: | THE INVACARE FLYER, MODEL IPC 100 |
| Classification | Generator, Oxygen, Portable |
| Applicant | INVACARE CORP. ONE INVACARE WAY P.O. BOX 4028 Elyria, OH 44036 -2125 |
| Contact | Carroll Martin |
| Correspondent | Carroll Martin INVACARE CORP. ONE INVACARE WAY P.O. 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 | 2007-07-12 |
| Decision Date | 2007-12-12 |
| Summary: | summary |