The following data is part of a premarket notification filed by Baxter Centre For Medical Research with the FDA for Sullivan Nasal Cpap System.
| Device ID | K882292 |
| 510k Number | K882292 |
| Device Name: | SULLIVAN NASAL CPAP SYSTEM |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| Applicant | BAXTER CENTRE FOR MEDICAL RESEARCH P.O. BOX 185, NORTH RYDE, 2113 376-380 LANE COVE ROAD North Ryde, N.s.w. 2113, AU |
| Contact | Chris Lynch |
| Correspondent | Chris Lynch BAXTER CENTRE FOR MEDICAL RESEARCH P.O. BOX 185, NORTH RYDE, 2113 376-380 LANE COVE ROAD North Ryde, N.s.w. 2113, AU |
| Product Code | BYE |
| CFR Regulation Number | 868.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-01 |
| Decision Date | 1988-06-21 |