K201418 is an FDA 510(k) clearance for the Sunset Heated CPAP Tube. This device is classified as a Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer (Class II - Special Controls, product code BZE).
Submitted by Sunset Healthcare Solutions, Inc. (Chicago, US). The FDA issued a Cleared decision on January 29, 2021, 245 days after receiving the submission on May 29, 2020.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5270.
| 510(k) Number | K201418 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 2020 |
| Decision Date | January 29, 2021 |
| Days to Decision | 245 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZE — Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5270 |