Duns Number:757852710
Device Description: The M3DICINE Stethee™ Pro 1 is an electronic stethoscope intended for medical screening or The M3DICINE Stethee™ Pro 1 is an electronic stethoscope intended for medical screening or diagnostic purposes only. Stethee Pro 1 may be used for detection and amplification of sounds from the heart, lungs, arteries, veins, and other internal organs with or without the use of selective filters. It can be used on any person undergoing a physical assessment. Stethee Pro 1 is intended for use with the Stethee Pro Software System, whose features enable sample recording, playback, visualization, analysis, reporting and sharing with other authorized users.
Catalog Number
-
Brand Name
Stethee Pro
Version/Model Number
1
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
K172296,K193631
Product Code
DQD
Product Code Name
Stethoscope, Electronic
Public Device Record Key
9d7d735a-c137-4846-b9a9-f2638b5e90b6
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
April 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 |