The following data is part of a premarket notification filed by Resmed Ltd. with the FDA for Sullivan Vpap Ii St Nasal Vpap System.
| Device ID | K961783 |
| 510k Number | K961783 |
| Device Name: | SULLIVAN VPAP II ST NASAL VPAP SYSTEM |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | RESMED LTD. 82 WATERLOO RD. NORTH RYDE Sydney, New South Wales, AU 2113 |
| Contact | Helen Meler |
| Correspondent | Helen Meler RESMED LTD. 82 WATERLOO RD. NORTH RYDE Sydney, New South Wales, AU 2113 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-08 |
| Decision Date | 1996-08-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00619498149117 | K961783 | 000 |