The following data is part of a premarket notification filed by Resmed Ltd. with the FDA for Sullivan Autoset Nasal Cpap System.
| Device ID | K984428 |
| 510k Number | K984428 |
| Device Name: | SULLIVAN AUTOSET NASAL CPAP SYSTEM |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | RESMED LTD. 10121 CARROLL CANYON RD. San Diego, CA 92131 |
| Contact | Scott Dudevoir |
| Correspondent | Scott Dudevoir RESMED LTD. 10121 CARROLL CANYON RD. San Diego, CA 92131 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-04 |
| Decision Date | 1999-07-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00619498166374 | K984428 | 000 |
| 00619498166244 | K984428 | 000 |
| 00619498166176 | K984428 | 000 |
| 00619498166138 | K984428 | 000 |
| 00619498166060 | K984428 | 000 |
| 00619498166053 | K984428 | 000 |
| 00619498166046 | K984428 | 000 |