The following data is part of a premarket notification filed by Life Design Systems, Inc. with the FDA for Flow Generator For Sleep Apnea, Lds 1500.
| Device ID | K862448 |
| 510k Number | K862448 |
| Device Name: | FLOW GENERATOR FOR SLEEP APNEA, LDS 1500 |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | LIFE DESIGN SYSTEMS, INC. 11017 WEST LAYTON AVE. Milwaukee, WI 53228 |
| Contact | Gilbert Kirk |
| Correspondent | Gilbert Kirk LIFE DESIGN SYSTEMS, INC. 11017 WEST LAYTON AVE. Milwaukee, WI 53228 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-27 |
| Decision Date | 1986-11-14 |