LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES— 510(k) K012218
Substantially EquivalentThe Ludlow Company LP
FDA 510(k) clearance K012218 for LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES, Substantially Equivalent on 2001-10-12. Applicant: The Ludlow Company LP. Device class: 2.
Clearance details
- Applicant
- The Ludlow Company LP
- Product code
- Code DRO
- Device class
- Class 2
- Regulation
- 21 CFR 870.5550
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chicopee, MA, US
Recent devices under product code DRO
view all- K012404 — K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85
- K000660 — ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413
- K983196 — PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)
- K983232 — PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT
- K974034 — PORTABLE INTENSIVE CARE UNIT
More clearances from The Ludlow Company LP
view allRecalls naming K012218
K-number listed on FDA's recall record- Z-2545-2015 — MediTrace Cadence Adult Multi-Function Defibrillation Electrodes Item Code:22550PC
- Z-2546-2015 — MediTrace Cadence Adult Zoll, Preconnect Defibrillation Electrode, Nonsterile Item Code:22770PC
- Z-0043-2015 — Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes, Radiotransparent Part Number: 22660R
- Z-0044-2015 — Coviden Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pre-connected Part Number: 22660PC
- Z-0045-2015 — Covidien Kendall Adult Multi-Function Defibrillation Electrodes Part Number: 20660
- Z-0048-2015 — Philips HEARTSTART Multifunction Electrode Pads Part Number: M3718A
- Z-1184-2013 — Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product ID: 22550R. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
- Z-1185-2013 — Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID: 22550P. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K012218.
Data sourced from openFDA. This site is unofficial and independent of the FDA.