HolterCare - The ScottCare HolterCare Analysis System is - SCOTTCARE CORPORATION, THE

Duns Number:808204957

Device Description: The ScottCare HolterCare Analysis System is intended for general hospital or clinical use The ScottCare HolterCare Analysis System is intended for general hospital or clinical use bymedical professionals whenever it is required to assess a patient’s long-term, continuous,ambulatory electrocardiogram (ECG). The long-term ECG is recorded on a digital flash memoryHolter recorder. This product allows a trained physician, or other health care professional, todownload and analyze the data from the recorder, review it, and produce printed reports. This willenable: The evaluation of arrhythmias and ischemic attacks. The reporting of PQRST intervals. Clinical and epidemiological research studies. The evaluation of a patient’s response after resuming occupational or recreational activities (e.g.,after M.I. or cardiac surgery). The evaluation of patients with Pacemakers.The need to record, review, edit, and archive the ambulatory ECG is most commonly encountered inthe Cardiology areas of the hospital, or physician’s office, during cardiac assessment of a patient.This device is available for sale to, or on the order of, a licensed physician only and is not intendedfor any home-use applications.

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More Product Details

Catalog Number

100087

Brand Name

HolterCare

Version/Model Number

HolterCare

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K042463

Product Code Details

Product Code

DQK

Product Code Name

Computer, Diagnostic, Programmable

Device Record Status

Public Device Record Key

579ccc3e-ebc6-46cc-86ae-223337185128

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 19, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SCOTTCARE CORPORATION, THE" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 32