LECTEC NON-INVASIVE PACING ELECTRODE— 510(k) K872012

Name: FDA 510(k) clearance K872012
Creator: U.S. Food and Drug Administration
Published: 1987-06-29

Substantially Equivalent

Lectec Corp.

FDA 510(k) clearance K872012 for LECTEC NON-INVASIVE PACING ELECTRODE, Substantially Equivalent on 1987-06-29. Applicant: Lectec Corp.. Device class: 2.

Clearance details

Applicant: Lectec Corp.
Product code: Code DRO
Device class: Class 2
Regulation: 21 CFR 870.5550
Advisory panel: Cardiovascular
Date received: 1987-05-26
Decision date: 1987-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DRO

view all

K012218 — LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES2001-10-12
K012404 — K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-852001-10-12
K000660 — ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 204132000-03-28
K983196 — PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)1999-09-15
K983232 — PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT1999-09-15

More clearances from Lectec Corp.

view all

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

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