Duns Number:059636679
Device Description: Intraoral appliance for the treatment of snoring and mild to moderate obstructive sleep ap Intraoral appliance for the treatment of snoring and mild to moderate obstructive sleep apnea with patient monitoring.
Catalog Number
-
Brand Name
Respire Pink Series H/S with DentiTrac
Version/Model Number
SPD020US
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
K170692
Product Code
PLC
Product Code Name
Sleep Appliances With Patient Monitoring
Public Device Record Key
e4d2b089-f601-4daa-89ea-a9717ee6661b
Public Version Date
February 17, 2020
Public Version Number
5
DI Record Publish Date
July 14, 2017
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. | 28 |