DROWZLE PRO is indicated to record a patient’s respiratory pattern during sleep for the purpose of prescreening patients for obstructive sleep apnea syndrome. The device is designed for use…
DROWZLE PRO is indicated to record a patient’s respiratory pattern during sleep for the purpose of prescreening patients for obstructive sleep apnea syndrome. The device is designed for use in home-screening of adults with suspected possible sleep breathing disorders. Results are used to assist the healthcare professional in determining the need for further diagnosis and evaluation. The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stastages, limb movements, or EEG activity are required
Who Else Makes It
Concentrated in Fujian (1), Jiangsu (1), Guangdong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Drowzle Pro | Listed by | Resonea, Inc., United States |
| FDA product code | MNR |
| Device type | Ventilatory Effort Recorder |
| Device class | Class 2 |
| Regulation | 21 CFR 868.2375 |
| 510(k) | K173974 |
| Record published | 2020-11-04 |
| Record revised | 2023-06-02 (version 2) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.