The following data is part of a premarket notification filed by Resmed Ltd. with the FDA for S7 Elite And Autoset Spirit Cpap Systems With Reslink.
| Device ID | K024191 |
| 510k Number | K024191 |
| Device Name: | S7 ELITE AND AUTOSET SPIRIT CPAP SYSTEMS WITH RESLINK |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | RESMED LTD. 14040 DANIELSON ST. Poway, CA 92064 -6857 |
| Contact | Roger Kotter |
| Correspondent | Roger Kotter RESMED LTD. 14040 DANIELSON ST. Poway, CA 92064 -6857 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-20 |
| Decision Date | 2003-07-02 |
| Summary: | summary |