The following data is part of a premarket notification filed by Bird Life Design with the FDA for Bld-18000 Series Heated Breathing Circuit.
| Device ID | K925543 |
| 510k Number | K925543 |
| Device Name: | BLD-18000 SERIES HEATED BREATHING CIRCUIT |
| Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
| Applicant | BIRD LIFE DESIGN 2735 EAST BELT LINE RD. Carrollton, TX 75006 |
| Contact | James Antosh |
| Correspondent | James Antosh BIRD LIFE DESIGN 2735 EAST BELT LINE RD. Carrollton, TX 75006 |
| Product Code | CAI |
| CFR Regulation Number | 868.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-05 |
| Decision Date | 1993-04-30 |