ECG ELECTRODE— 510(k) K944260

Name: FDA 510(k) clearance K944260
Creator: U.S. Food and Drug Administration
Published: 1995-07-07

Substantially Equivalent

Msb , Ltd.

FDA 510(k) clearance K944260 for ECG ELECTRODE, Substantially Equivalent on 1995-07-07. Applicant: Msb , Ltd.. Device class: 2.

Clearance details

Applicant: Msb , Ltd.
Product code: Code DRX
Device class: Class 2
Regulation: 21 CFR 870.2360
Advisory panel: Cardiovascular
Date received: 1994-08-30
Decision date: 1995-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlborough, Wiltshire, GB

Download summary PDF View on FDA.gov ↗

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More clearances from Msb , Ltd.

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K980229 — MSB TENS ELECTRODES (DISPOSABLE)1998-02-27
K944497 — UNILECT, MONITAB AND BIOTRACE-HR1996-05-17
K944496 — BIOTRACE-N, NS, 410 AND RT1996-05-16
K955261 — NEUTRALECT ADULT STANDARD, RETURN (REM) & PAEDIATRIC ELECTROSURGERY PLATE (MODIFICATION)1996-01-30
K950587 — ECOTABS1995-10-16

Adverse events under product code DRX

product code DRX

Death: 6
Injury: 476
Other: 2
Total: 484

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.