The following data is part of a premarket notification filed by Life Design Systems, Inc. with the FDA for Babyset Tm & Pac Tm -pulmonary Assist.
| Device ID | K841264 |
| 510k Number | K841264 |
| Device Name: | BABYSET TM & PAC TM -PULMONARY ASSIST |
| Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
| Applicant | LIFE DESIGN SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CAI |
| CFR Regulation Number | 868.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-26 |
| Decision Date | 1984-06-15 |