Duns Number:020904101
Device Description: Oral Appliance System for Snoring and Obstructive Sleep ApneaPack contains:(1) Size A mout Oral Appliance System for Snoring and Obstructive Sleep ApneaPack contains:(1) Size A mouthpiece- +0 mm advancement(1) Size A mouthpiece- +2 mm advancement(1) Size A mouthpiece- +4 mm advancement(1) Size A mouthpiece- +6 mm advancement(1) Storage case
Catalog Number
-
Brand Name
ZQuiet S.A.
Version/Model Number
ZQSA-XM
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
K140777
Product Code
LRK
Product Code Name
Device, Anti-Snoring
Public Device Record Key
91e1895c-2765-43bb-bc1b-76feb0e6b7b2
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
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 |