The following data is part of a premarket notification filed by Bird Products Corp. with the FDA for Bird Avea Ventilator.
| Device ID | K022674 |
| 510k Number | K022674 |
| Device Name: | BIRD AVEA VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | BIRD PRODUCTS CORP. 555 THIRTEENTH STREET, NW Washington, DC 20004 -1109 |
| Contact | Jeffrey K Shapiro |
| Correspondent | Jeffrey K Shapiro BIRD PRODUCTS CORP. 555 THIRTEENTH STREET, NW Washington, DC 20004 -1109 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-12 |
| Decision Date | 2002-11-06 |
| Summary: | summary |