Duns Number:537208717
Device Description: Stethoscopes are sound-conducting instruments to be used for auscultation of body and orga Stethoscopes are sound-conducting instruments to be used for auscultation of body and organ sounds, especially of heart and lung; meaning they are used in order to diagnose illness of internal organs.In medical science, doctors or other trained medical professionals use a stethoscope in order to assess sounds and noises linked with the function of heart, lung and bowel. During blood pressure measurement, a stethoscope is used to capture Korotkow blood flow murmur (Korotkow sounds) leading to determination of systolic and diastolic blood pressure.
Catalog Number
4230-02
Brand Name
Stethoscope duplex® 2.0 neonatal, white
Version/Model Number
4230-02
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K944337
Product Code
LDE
Product Code Name
Stethoscope, Manual
Public Device Record Key
25350e27-c6d6-41a4-b835-5f011d0a0173
Public Version Date
February 05, 2021
Public Version Number
1
DI Record Publish Date
January 28, 2021
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 | 282 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 332 |