SIGNA II RESTING ECG ELECTRODE— 510(k) K862655

Name: FDA 510(k) clearance K862655
Creator: U.S. Food and Drug Administration
Published: 1986-08-06

Substantially Equivalent

Kone Instruments, Inc.

FDA 510(k) clearance K862655 for SIGNA II RESTING ECG ELECTRODE, Substantially Equivalent on 1986-08-06. Applicant: Kone Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Kone Instruments, Inc.
Product code: Code DRX
Device class: Class 2
Regulation: 21 CFR 870.2360
Advisory panel: Cardiovascular
Date received: 1986-07-14
Decision date: 1986-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milton, WI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DRX

view all

K171244 — Physiotrace2017-08-23
K140096 — HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE2014-07-24
K123658 — BIOMODULE 3-M12013-04-24
K101576 — CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES2010-07-22
K101685 — IP-SET2010-07-01

More clearances from Kone Instruments, Inc.

view all

K873345 — 'MICROLYTE 4/5'1987-09-11
K870777 — PROGRESS PLUS SELECTIVE CHEMISTRY ANALYZER1987-03-13
K863466 — M700 STRESS MONITOR1986-12-22
K860767 — MODEL E 600 ELECTROCARDIOGRAPH1986-04-23
K853354 — MEDIC 41985-10-11

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.