Duns Number:480868538
Device Description: The CARDIOVIT® FT-1 is a 12-lead ECG device used for the recording, analysis and evaluatio The CARDIOVIT® FT-1 is a 12-lead ECG device used for the recording, analysis and evaluation of ECG recordings
Catalog Number
3.900860
Brand Name
CARDIOVIT® FT-1
Version/Model Number
3.900860
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
K170182
Product Code
DPS
Product Code Name
Electrocardiograph
Public Device Record Key
9444888e-223d-4210-b52c-611267a4c543
Public Version Date
March 10, 2021
Public Version Number
5
DI Record Publish Date
August 02, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 93 |