The following data is part of a premarket notification filed by Resmed Ltd. with the FDA for Resmed S8 Pioneer Cpap System.
| Device ID | K041209 |
| 510k Number | K041209 |
| Device Name: | RESMED S8 PIONEER CPAP SYSTEM |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | RESMED LTD. 14040 DANIELSON ST. Poway, CA 92064 -6857 |
| Contact | David D'cruz |
| Correspondent | David D'cruz 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 | 2004-05-10 |
| Decision Date | 2004-07-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00619498229611 | K041209 | 000 |
| 00619498219261 | K041209 | 000 |