The following data is part of a premarket notification filed by Resmed Ltd. with the FDA for Sullivan Autoset Home Nasal Cpap System.
| Device ID | K970516 |
| 510k Number | K970516 |
| Device Name: | SULLIVAN AUTOSET HOME NASAL CPAP SYSTEM |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | RESMED LTD. 82 WATERLOO RD. NORTH RYDE Sydney, New South Wales, AU 2113 |
| Contact | Michael Hallett |
| Correspondent | Michael Hallett 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 | 1997-02-11 |
| Decision Date | 1997-05-09 |