The following data is part of a premarket notification filed by Invacare Corporation with the FDA for Invacare Pro, Compact And Portable Desktop.
| Device ID | K042483 |
| 510k Number | K042483 |
| Device Name: | INVACARE PRO, COMPACT AND PORTABLE DESKTOP |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | INVACARE CORPORATION ONE INVACARE WAY Elyria, OH 44035 -4190 |
| Contact | Carroll Martin |
| Correspondent | Carroll Martin INVACARE CORPORATION ONE INVACARE WAY Elyria, OH 44035 -4190 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-13 |
| Decision Date | 2005-01-06 |
| Summary: | summary |