The following data is part of a premarket notification filed by Resmed Corp. with the FDA for Sullivan Humidaire Heated Humidifier.
| Device ID | K971260 |
| 510k Number | K971260 |
| Device Name: | SULLIVAN HUMIDAIRE HEATED HUMIDIFIER |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | RESMED CORP. 5744 PACIFIC CENTER BLVD., SUITE 311 San Diego, CA 92121 |
| Contact | Michael Hallett |
| Correspondent | Michael Hallett RESMED CORP. 5744 PACIFIC CENTER BLVD., SUITE 311 San Diego, CA 92121 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-04 |
| Decision Date | 1997-09-04 |