The following data is part of a premarket notification filed by Life Design Systems, Inc. with the FDA for Babyset(tm) Modified Jackson-rees Circuit W/valve.
| Device ID | K871669 |
| 510k Number | K871669 |
| Device Name: | BABYSET(TM) MODIFIED JACKSON-REES CIRCUIT W/VALVE |
| Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
| Applicant | LIFE DESIGN SYSTEMS, INC. 5900 WEST FRANKLIN DR. Franklin, WI 53132 |
| Contact | Alan E Whitmarsh |
| Correspondent | Alan E Whitmarsh LIFE DESIGN SYSTEMS, INC. 5900 WEST FRANKLIN DR. Franklin, WI 53132 |
| Product Code | CAI |
| CFR Regulation Number | 868.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-28 |
| Decision Date | 1987-05-19 |