Duns Number:480868538
Device Description: The CARDIOVIT® AT-101 is a 12-lead ECG device used for the recording, analysis and evaluat The CARDIOVIT® AT-101 is a 12-lead ECG device used for the recording, analysis and evaluation of ECG recordings.
Catalog Number
3.920963
Brand Name
CARDIOVIT® AT-101
Version/Model Number
3.920963
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K031557
Product Code
DPS
Product Code Name
Electrocardiograph
Public Device Record Key
36ecbaac-4600-4e4e-a306-30fa6c4dbe81
Public Version Date
March 10, 2021
Public Version Number
5
DI Record Publish Date
September 18, 2016
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 |