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HolterCare

FDA UDI

Class II (US FDA UDI)

by Scottcare Corporation, The

Identity

Trade Name
HolterCare FDA UDI
Generic Name
Electrocardiographic long-term ambulatory recording analyser application software FDA UDI
Device Name
The ScottCare HolterCare Analysis System is intended for general hospital or clinical use by medical 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 memory Holter recorder. This product allows a trained physician, or other health care professional, to download and analyze the data from the recorder, review it, and produce printed reports. This will enable:  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 in the 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 intended for any home-use applications. FDA UDI
Model / Reference
HolterCare FDA UDI
Description
The ScottCare HolterCare Analysis System is intended for general hospital or clinical use by medical 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 memory Holter recorder. This product allows a trained physician, or other health care professional, to download and analyze the data from the recorder, review it, and produce printed reports. This will enable:  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 in the 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 intended for any home-use applications. FDA UDI

Identifiers

Catalog Number
100087 FDA UDI
Primary DI / UDI-DI
00856298006169 FDA UDI
510(k) Number
K042463 FDA UDI
FDA Product Code
DQK FDA UDI
GMDN Term
Electrocardiographic long-term ambulatory recording analyser application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1425 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Electrocardiographic long-term ambulatory recording analyser application software

HolterCare by Scottcare Corporation, The — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocardiographic long-term ambulatory recording analyser application software.

Cleared under the same submission

K042463 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Scottcare Corporation, The

Sources (1)

  • FDA UDI 579ccc3e-ebc6-46cc-86ae-223337185128 36 fields · synced Jun 8, 2026