The following data is part of a premarket notification filed by Bird Life Design with the FDA for Barrierflex-i, And Barrierfles-ii.
| Device ID | K934189 |
| 510k Number | K934189 |
| Device Name: | BARRIERFLEX-I, AND BARRIERFLES-II |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | BIRD LIFE DESIGN 4450 ALPHA RD. Dallas, TX 75244 -4505 |
| Contact | Rebecca D Fuller |
| Correspondent | Rebecca D Fuller BIRD LIFE DESIGN 4450 ALPHA RD. Dallas, TX 75244 -4505 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-26 |
| Decision Date | 1993-11-24 |