The following data is part of a premarket notification filed by Bird Products Corp. with the FDA for Bird Tbird Vela Ventilator.
| Device ID | K032451 |
| 510k Number | K032451 |
| Device Name: | BIRD TBIRD VELA VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | BIRD PRODUCTS CORP. 1100 BIRD CENTER DR. Palm Springs, CA 92262 |
| Contact | Tom Gutierrez |
| Correspondent | Tom Gutierrez BIRD PRODUCTS CORP. 1100 BIRD CENTER DR. Palm Springs, CA 92262 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-11 |
| Decision Date | 2004-03-17 |
| Summary: | summary |