The following data is part of a premarket notification filed by Resmed Corp. with the FDA for S7 Elite Cpap System With Somnotraxx System; Autoset Spirit Cpap System With Somnotraxx System.
| Device ID | K030797 |
| 510k Number | K030797 |
| Device Name: | S7 ELITE CPAP SYSTEM WITH SOMNOTRAXX SYSTEM; AUTOSET SPIRIT CPAP SYSTEM WITH SOMNOTRAXX SYSTEM |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | RESMED CORP. 14040 DANIELSON ST. Poway, CA 92064 -6857 |
| Contact | David D'cruz |
| Correspondent | David D'cruz RESMED CORP. 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 | 2003-03-13 |
| Decision Date | 2004-03-10 |
| Summary: | summary |