Duns Number:431076243
Device Description: CER-S is stand-alone software medical device, providing advanced solutions for importing, CER-S is stand-alone software medical device, providing advanced solutions for importing, analyzing, editing, reviewing and generating clinical reports related to digital continuous ECG recordings (Holters). CER-S does not carry out an automated interpretation of the ECG data.
Catalog Number
CCZ1205048205
Brand Name
CER-S
Version/Model Number
4
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K213861
Product Code
DQK
Product Code Name
Computer, Diagnostic, Programmable
Public Device Record Key
87b1b62a-603b-4174-8305-1039b558c288
Public Version Date
June 07, 2022
Public Version Number
1
DI Record Publish Date
May 30, 2022
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. | 2 |