K971260 is an FDA 510(k) clearance for the SULLIVAN HUMIDAIRE HEATED HUMIDIFIER. This device is classified as a Humidifier, Respiratory Gas, (direct Patient Interface) (Class II - Special Controls, product code BTT).
Submitted by ResMed Corp (San Diego, US). The FDA issued a Cleared decision on September 4, 1997, 153 days after receiving the submission on April 4, 1997.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5450.
| 510(k) Number | K971260 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 1997 |
| Decision Date | September 04, 1997 |
| Days to Decision | 153 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BTT - Humidifier, Respiratory Gas, (direct Patient Interface) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5450 |