Duns Number:079151785
Device Description: suiteHEART® Software is intended to assist trained clinical personnel in the qualification
Catalog Number
-
Brand Name
suiteHEART
Version/Model Number
3.0.1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 02, 2016
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K130228
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
a4a2bbf0-de67-42b7-b25a-72c11be88e04
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 23, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |