The following data is part of a premarket notification filed by Life Design Systems, Inc. with the FDA for Humidi-flex Tm.
| Device ID | K885313 |
| 510k Number | K885313 |
| Device Name: | HUMIDI-FLEX TM |
| Classification | Condenser, Heat And Moisture (artificial Nose) |
| Applicant | LIFE DESIGN SYSTEMS, INC. 5900 WEST FRANKLIN DR. Franklin, WI 53132 |
| Contact | Alan Whitmarsh |
| Correspondent | Alan Whitmarsh LIFE DESIGN SYSTEMS, INC. 5900 WEST FRANKLIN DR. Franklin, WI 53132 |
| Product Code | BYD |
| CFR Regulation Number | 868.5375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-29 |
| Decision Date | 1989-10-11 |