The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Invacare Polaris Ex Heated Humidifier, Model Isp4000.
| Device ID | K031176 |
| 510k Number | K031176 |
| Device Name: | INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000 |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | INVACARE CORP. ONE INVACARE WAY P.O. BOX 4028 Elyria, OH 44036 -2125 |
| Contact | Rae Ann Farrow |
| Correspondent | Rae Ann Farrow INVACARE CORP. ONE INVACARE WAY P.O. BOX 4028 Elyria, OH 44036 -2125 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-14 |
| Decision Date | 2004-03-25 |
| Summary: | summary |