The following data is part of a premarket notification filed by Life Design Systems, Inc. with the FDA for Filter-flex.
| Device ID | K841236 |
| 510k Number | K841236 |
| Device Name: | FILTER-FLEX |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | LIFE DESIGN SYSTEMS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-22 |
| Decision Date | 1984-04-05 |