The following data is part of a premarket notification filed by Bird Products Corp. with the FDA for Bird Nightbird Nasal Cpap System.
| Device ID | K863746 |
| 510k Number | K863746 |
| Device Name: | BIRD NIGHTBIRD NASAL CPAP SYSTEM |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | BIRD PRODUCTS CORP. 1100 BIRD CENTER DR. Palm Springs, CA 92262 |
| Contact | William C Bentinck |
| Correspondent | William C Bentinck BIRD PRODUCTS CORP. 1100 BIRD CENTER DR. Palm Springs, CA 92262 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-24 |
| Decision Date | 1986-12-15 |