Duns Number:198227881
Device Description: Welch Allyn CardioPerfect Workstation with PC-Based 12-Lead Resting Electrocardiograph, Au Welch Allyn CardioPerfect Workstation with PC-Based 12-Lead Resting Electrocardiograph, Automatic ECG Interpretation, AHA ECG Cable, PC-Based SpiroPerfect Spirometer, 64-Bit Operating System
Catalog Number
104060
Brand Name
Welch Allyn, Inc.
Version/Model Number
901047
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 25, 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
K072449
Product Code
BZG
Product Code Name
SPIROMETER, DIAGNOSTIC
Public Device Record Key
0be5f7d9-0a21-4b69-b60b-5bea26c292a7
Public Version Date
January 26, 2021
Public Version Number
4
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 |