AMI E-Z-PACE ELECTODE— 510(k) K854924
Substantially EquivalentA.M.I. Corp.
FDA 510(k) clearance K854924 for AMI E-Z-PACE ELECTODE, Substantially Equivalent on 1986-02-26. Applicant: A.M.I. Corp.. Device class: 2.
Clearance details
- Applicant
- A.M.I. Corp.
- 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
- Lawrence, MA, US
Recent devices under product code DRO
view all- K012218 — LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.