Duns Number:080481089
Device Description: Diagnostic ultrasound system with integrated electronic stethoscope and electrocardiograph Diagnostic ultrasound system with integrated electronic stethoscope and electrocardiographUltrasound/ electrocardiograph/ stethoscope unit
Catalog Number
-
Brand Name
Kosmos Bridge
Version/Model Number
P006030
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
K193518
Product Code
DPS
Product Code Name
Electrocardiograph
Public Device Record Key
888d613d-f11f-44f3-b846-c427fbe42888
Public Version Date
May 14, 2020
Public Version Number
1
DI Record Publish Date
May 06, 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 46 |