DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610

• K Number: K990112
• Device Name: DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610
• Manufacturer: MAERSK MEDICAL A/S
• Date Cleared: 1999-12-06 ( 327 days)
• Product Code: DRX
• Regulation Number: 870.2360

Intended Use

ECG monitoring electrodes for short-term use (<24 hours) in adults (Model 4060) and infants (Model 4610).

Device Description

Pregelled electrodes are of Ag/AgCl construction with a sensor element area between 10 and 20 mm in diameter, and an adhesive part between 20 and 55 mm in diameter or rectanqular/square in shape. Electrodes are bulk packaged in OPP/PE laminated pouches; 60/pouch; 300/box.

Predicate Devices

K950479

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard ECG electrodes and does not mention any AI/ML components or functionalities.

Therapeutic

No
The device is described as "ECG monitoring electrodes," indicating it is used for diagnostic monitoring and not for treating a condition.

Diagnostic

No
The device is described as "ECG monitoring electrodes," indicating they are used for collecting physiological signals, not for interpreting or analyzing them to diagnose a condition. The "Indications for Use" specifies "ECG monitoring electrodes for short-term use," which is a data acquisition function rather than a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical electrode, which is a hardware component.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is "ECG monitoring electrodes for short-term use (

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

ECG monitoring electrodes for short-term use (

Regulation Number and Section

§ 870.2360 Electrocardiograph electrode.

(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.

Summary

0

DFC - 6 1999

K990112

510 (k) SUMMARY

ADMINISTRATIVE 1.

Maersk Medical A/S Submitter: Niko Business Unit Engmosen 1 DK-3540, Lynge Denmark Phone No.: 011 45 48 16 70 30

Contact Person: Mr. Christian Pelch

Date of Preparation: October 15, 1999

• II. DEVICE NAME
  Proprietary Name: Niko ECG Monitoring Electrodes Common Name: ECG Electrode Classification Name: Electrocardiograph Electrode

PREDICATE DEVICES III.

Disposable ECG Monitoring Electrode Models 4600 and 4610 (K950479); Nikomed USA, Inc.

IV. DEVICE DESCRIPTION

Pregelled electrodes are of Ag/AgCl construction with a sensor element area between 10 and 20 mm in diameter, and an adhesive part between 20 and 55 mm in diameter or rectanqular/square in shape. Electrodes are bulk packaged in OPP/PE laminated pouches; 60/pouch; 300/box.

V. INTENDED USE

ECG monitoring electrodes for short-term use (