The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Twlight, Model Isp 9600.
| Device ID | K022642 |
| 510k Number | K022642 |
| Device Name: | TWLIGHT, MODEL ISP 9600 |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | INVACARE CORP. ONE INVACARE WAY Elyria, OH 44036 -2125 |
| Contact | Rae Ann Farrow |
| Correspondent | Rae Ann Farrow INVACARE CORP. ONE INVACARE WAY Elyria, OH 44036 -2125 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-08 |
| Decision Date | 2003-02-11 |
| Summary: | summary |