PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic System - The battery charger type PECGC-III is an - MEDICALGORITHMICS S A

Duns Number:522657576

Device Description: The battery charger type PECGC-III is an accessory to the PocketECG III - Medicalgorithmic The battery charger type PECGC-III is an accessory to the PocketECG III - Medicalgorithmics Unified Arrhythmia Diagnostic System. The charger is intended to be used for charging the PECGB-III batteries used with PocketECG transmitter.

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More Product Details

Catalog Number

-

Brand Name

PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic System

Version/Model Number

Type: PECGC-III

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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"

-

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

Product Code Details

Product Code

DSI

Product Code Name

Detector And Alarm, Arrhythmia

Device Record Status

Public Device Record Key

a1603138-a6d0-41c8-abbc-c3e2b02b2d8f

Public Version Date

July 23, 2018

Public Version Number

3

DI Record Publish Date

January 09, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDICALGORITHMICS S A" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 16