Duns Number:079132539
Device Description: DROWZLE PRO is indicated to record a patient’s respiratory pattern during sleep for the pu 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
Catalog Number
-
Brand Name
DROWZLE Pro
Version/Model Number
2.0
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K173974
Product Code
MNR
Product Code Name
Ventilatory Effort Recorder
Public Device Record Key
6f8533f0-9916-4f37-be75-9f04f293ba35
Public Version Date
November 12, 2020
Public Version Number
1
DI Record Publish Date
November 04, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |