The following data is part of a premarket notification filed by Resmed Corp. with the FDA for Sullivan Vpap Ii St-a Nasal Vpap System.
| Device ID | K974417 |
| 510k Number | K974417 |
| Device Name: | SULLIVAN VPAP II ST-A NASAL VPAP SYSTEM |
| Classification | Ventilator, Continuous, Non-life-supporting |
| Applicant | RESMED CORP. 10121 CAROLL CANYON RD. San Diego, CA 92131 |
| Contact | Scott Dudevoir |
| Correspondent | Scott Dudevoir RESMED CORP. 10121 CAROLL CANYON RD. San Diego, CA 92131 |
| Product Code | MNS |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-24 |
| Decision Date | 1998-06-24 |