Duns Number:522657576
Device Description: The PocketECG transmitter is a key component of PocketECG III - Medicalgorithmics Unified The PocketECG transmitter is a key component of PocketECG III - Medicalgorithmics Unified Arrhythmia Diagnostic System and is intended to: acquire, analyze, visualize, record or/and transmit the ECG and acceleration data. The PocketECG transmitter is attached to patient’s body with three electrodes. The device is battery powered from Lithium-ion battery (type: PECGB-III) with rated voltage of 3.7 V and is designed for continuous use. PocketECG transmitter type: PECGT-III is inteded for use in GSM cellular networks.
Catalog Number
-
Brand Name
PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic System
Version/Model Number
Type: PECGT-III
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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"
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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
Product Code
DSI
Product Code Name
Detector And Alarm, Arrhythmia
Public Device Record Key
4dc97c00-2246-4bd2-9710-1303de24d6fb
Public Version Date
July 23, 2018
Public Version Number
3
DI Record Publish Date
January 09, 2018
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 |