The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Invacare's Twilight Ii Nasal Masks.
| Device ID | K061874 |
| 510k Number | K061874 |
| Device Name: | INVACARE'S TWILIGHT II NASAL MASKS |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | INVACARE CORP. ONE INVACARE WAY Elyria, OH 44036 |
| Contact | Janice Brownlee |
| Correspondent | Janice Brownlee INVACARE CORP. ONE INVACARE WAY Elyria, OH 44036 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-03 |
| Decision Date | 2006-09-05 |
| Summary: | summary |