Bard Tab ECG Monitoring Electrode
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K890103 FDA 510(k)
- FDA Product Code
- DRX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2360 FDA 510(k)
- Regulation Number
- 870.2360 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Bard Tab ECG Monitoring Electrode is a cardiovascular device designed for the monitoring of electrocardiogram signals. It functions as a conductive interface to facilitate the capture of electrical activity from the patient's heart.
This device is regulated under FDA 510(k) clearance K890103 and is classified under regulation number 870.2360. It is intended for use in a cardiovascular clinical setting as a class 2 medical device.
Frequently asked questions
What is the primary function of the Bard Tab ECG Monitoring Electrode?
This device serves as a conductive interface used in cardiovascular clinical settings to facilitate the capture and monitoring of electrical activity from the patient's heart for electrocardiogram signals.
How is this device classified for regulatory purposes?
The Bard Tab ECG Monitoring Electrode is classified as a class 2 medical device under regulation number 870.2360 and has received FDA 510(k) clearance under reference number K890103.
In what environment is this electrode intended to be used?
The device is specifically intended for use within a cardiovascular clinical setting, where it is utilized to monitor electrocardiogram signals as part of standard cardiac assessment procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BARD TAB ECG MONITORING ELECTRODE (K890103) - FDA 510 (k), Bard Tab Ecg Monitoring Electrode - Beudamed, PDF K890103 - Bard Tab Ecg Monitoring Electrode
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K890103 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K890103 24 fields · synced Sep 24, 2026