The following data is part of a premarket notification filed by Bird Products Corp. with the FDA for Heritage Nasal Cpap System, Model P/n 15682.
| Device ID | K990856 |
| 510k Number | K990856 |
| Device Name: | HERITAGE NASAL CPAP SYSTEM, MODEL P/N 15682 |
| Classification | Ventilator, Non-continuous (respirator) |
| 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 | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-15 |
| Decision Date | 2000-01-11 |
| Summary: | summary |