Duns Number:480868538
Device Description: The Diagnostic Station DS20 is a 12-lead ECG device that is intended for use in the record The Diagnostic Station DS20 is a 12-lead ECG device that is intended for use in the recording, analysis and evaluation of ECG waveforms. The DS20 is also intended for the collection and recording of basic vital signs on adult and pediatric patients, excluding neonates.
Catalog Number
3.930535
Brand Name
Diagnostic Station DS20
Version/Model Number
3.930535
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
K152043
Product Code
BZG
Product Code Name
Spirometer, Diagnostic
Public Device Record Key
01adb9cf-8542-47f7-841a-e89e20fde379
Public Version Date
March 10, 2021
Public Version Number
5
DI Record Publish Date
September 19, 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 |