Duns Number:198227881
Device Description: PCE-210 PC-Based Exercise Stress System; 12-Lead Stress Test System (includes CardioPerfec PCE-210 PC-Based Exercise Stress System; 12-Lead Stress Test System (includes CardioPerfect workstation software, resting ECG functionality, digital ECG patient cable with USB connection, treadmill, stress belt, stress electrodes, manuals on CD, desktop computer, laser printer and cart)
Catalog Number
CPSP-UN-UC-D-PT
Brand Name
Welch Allyn, Inc.
Version/Model Number
901047
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 17, 2021
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
K141582
Product Code
DPS
Product Code Name
ELECTROCARDIOGRAPH
Public Device Record Key
a8190194-eccd-4807-a8c9-f9b756f2e4f6
Public Version Date
March 18, 2021
Public Version Number
7
DI Record Publish Date
September 17, 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 | 374 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4080 |
| 3 | A medical device with high risk that requires premarket approval | 1 |