The following data is part of a premarket notification filed by Bird Life Design with the FDA for Babyset And Pac (pulmonary Assist Circuit).
| Device ID | K930252 |
| 510k Number | K930252 |
| Device Name: | BABYSET AND PAC (PULMONARY ASSIST CIRCUIT) |
| Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
| Applicant | BIRD LIFE DESIGN 2735 EAST BELT LINE RD. Carrollton, TX 75006 |
| Contact | Allen |
| Correspondent | Allen 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 | 1993-01-08 |
| Decision Date | 1993-02-09 |