The following data is part of a premarket notification filed by Bird Life Design with the FDA for Bld Neonatal Heated Wire Breathing Circuit- 30 Volt Compatible.
| Device ID | K933641 |
| 510k Number | K933641 |
| Device Name: | BLD NEONATAL HEATED WIRE BREATHING CIRCUIT- 30 VOLT COMPATIBLE |
| Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
| 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 | CAI |
| CFR Regulation Number | 868.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-27 |
| Decision Date | 1993-10-15 |