The following data is part of a premarket notification filed by Bird Products Corp. with the FDA for Bird 1000 Pv Portable Ventilator.
| Device ID | K925422 |
| 510k Number | K925422 |
| Device Name: | BIRD 1000 PV PORTABLE VENTILATOR |
| Classification | Bottle, Collection And Trap, Breathing System (uncalibrated) |
| Applicant | BIRD PRODUCTS CORP. 1100 BIRD CENTER DR. Palm Springs, CA 92262 |
| Contact | Bentinck |
| Correspondent | Bentinck BIRD PRODUCTS CORP. 1100 BIRD CENTER DR. Palm Springs, CA 92262 |
| Product Code | CBC |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-27 |
| Decision Date | 1993-05-13 |