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510(k) K012218

LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES by The Ludlow Company LP — Product Code DRO

K012218 is an FDA 510(k) premarket notification submitted by The Ludlow Company LP for the device "LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES". The FDA issued a decision of Substantially Equivalent on October 12, 2001. The device falls under product code DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)), a Class II device regulated under 21 CFR 870.5550. The Ludlow Company LP has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 2001
Date Received
July 16, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Device Class
Class II
Regulation Number
870.5550
Review Panel
CV
Submission Type

Other clearances by The Ludlow Company LP

  • K021132 — UNI-PATCH ULTRASOUND COUPLING GEL (May 15, 2002)
  • K003511 — KENDALL-LTP TURNER SAVE-A-LINE (January 24, 2001)

Other clearances for product code DRO

  • K012404 — K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 (October 12, 2001)
  • K000660 — ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS (March 28, 2000)
  • K983232 — PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2 (September 15, 1999)
  • K983196 — PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) (September 15, 1999)
  • K974034 — PORTABLE INTENSIVE CARE UNIT (March 2, 1998)
  • K962547 — CARDIOSERV P (March 6, 1997)
  • K963120 — RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM (February 28, 1997)
  • K961138 — ESORT II + 400 SERIES MONITOR (December 10, 1996)
  • K951593 — LIFEPAK 11 (December 29, 1995)
  • K950856 — ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY (December 29, 1995)

FDA data resources