The following data is part of a premarket notification filed by Bird Products Corp. with the FDA for Dird Ingant O2 (bio 2 Hood).
| Device ID | K895866 |
| 510k Number | K895866 |
| Device Name: | DIRD INGANT O2 (BIO 2 HOOD) |
| Classification | Tent, Oxygen |
| Applicant | BIRD PRODUCTS CORP. 1100 BIRD CENTER DR. Palm Springs, CA 92262 |
| Contact | W. C Bentinck |
| Correspondent | W. C Bentinck BIRD PRODUCTS CORP. 1100 BIRD CENTER DR. Palm Springs, CA 92262 |
| Product Code | BYL |
| CFR Regulation Number | 868.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-04 |
| Decision Date | 1989-10-27 |