Duns Number:522657576
Device Description: The PC Client software is an accessory to the PocketECG III - Medicalgorithmics Unified Ar The PC Client software is an accessory to the PocketECG III - Medicalgorithmics Unified Arrhythmia Diagnostic System. The PC Client application allows managing the recording sessions and reviewing the ECG data that was recorded by the patient monitors.
Catalog Number
-
Brand Name
PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic System
Version/Model Number
Type: PC Client
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K124060,K152550,K173969,K193104
Product Code
DSI
Product Code Name
Detector And Alarm, Arrhythmia
Public Device Record Key
db7b7412-7397-4ce0-b3a3-2283e3ad4982
Public Version Date
August 08, 2022
Public Version Number
4
DI Record Publish Date
December 18, 2017
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. | 16 |