Duns Number:757852710
Device Description: Stethee Pro Mobile iOS Application is a component of the Stethee Pro Software System. The Stethee Pro Mobile iOS Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
Catalog Number
-
Brand Name
Stethee Pro Mobile iOS Application
Version/Model Number
2.0.X
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
K193631
Product Code
BZQ
Product Code Name
Monitor, Breathing Frequency
Public Device Record Key
6e24a754-e1cc-4886-aafd-b433cfd7b332
Public Version Date
December 31, 2020
Public Version Number
1
DI Record Publish Date
December 23, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |