Duns Number:748034696
Device Description: The O2Vent Optima is a removable medical device that is fitted in the patient’s mouth and The O2Vent Optima is a removable medical device that is fitted in the patient’s mouth and is intended to reduce oralleviate snoring and mild to moderate obstructive sleep apnea (OSA). The device is indicated for use during sleep to aidin the treatment of these conditions.
Catalog Number
-
Brand Name
O2Vent Optima
Version/Model Number
O2Vent Optima
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
K190236
Product Code
LRK
Product Code Name
Device, Anti-Snoring
Public Device Record Key
b5791608-232f-46c4-8496-f802f092f1ae
Public Version Date
January 13, 2020
Public Version Number
1
DI Record Publish Date
January 03, 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. | 5 |