TRACETS 2000/ELECTRODES— 510(k) K863674

Name: FDA 510(k) clearance K863674
Creator: U.S. Food and Drug Administration
Published: 1987-03-11

Substantially Equivalent

Lectec Corp.

FDA 510(k) clearance K863674 for TRACETS 2000/ELECTRODES, Substantially Equivalent on 1987-03-11. Applicant: Lectec Corp.. Device class: 2.

Clearance details

Applicant: Lectec Corp.
Product code: Code DRX
Device class: Class 2
Regulation: 21 CFR 870.2360
Advisory panel: Cardiovascular
Date received: 1986-09-19
Decision date: 1987-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DRX

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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 Lectec Corp.

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K950943 — ULTRA EASE1996-03-07
K925384 — ISOPORE(TM) TAPE, MODIFICATION1993-04-21
K930258 — TRACET T-60001993-04-16
K923558 — ECG ELECTRODE1993-02-18
K922959 — ISOPORE TAPE1992-09-11

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.