The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Twilight Full Face Mask.
| Device ID | K070321 |
| 510k Number | K070321 |
| Device Name: | TWILIGHT FULL FACE MASK |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | INVACARE CORP. ONE INVACARE WAY Elyria, OH 44035 -4190 |
| Contact | Carroll Martin |
| Correspondent | Carroll Martin INVACARE CORP. ONE INVACARE WAY Elyria, OH 44035 -4190 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-02 |
| Decision Date | 2007-04-30 |
| Summary: | summary |