ZOLL PD 2200 PACING-DEFIBRILLATION ELECTRODES— 510(k) K895032

Name: FDA 510(k) clearance K895032
Creator: U.S. Food and Drug Administration
Published: 1989-10-12

Substantially Equivalent

Zmi Corp.

FDA 510(k) clearance K895032 for ZOLL PD 2200 PACING-DEFIBRILLATION ELECTRODES, Substantially Equivalent on 1989-10-12. Applicant: Zmi Corp.. Device class: 2.

Clearance details

Applicant: Zmi Corp.
Product code: Code LDD
Device class: Class 2
Regulation: 21 CFR 870.5300
Advisory panel: Cardiovascular
Date received: 1989-08-08
Decision date: 1989-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LDD

view all

K203231 — Switched Internal Paddles2021-01-11
K200849 — Tempus LS - Manual2020-07-24
K182503 — Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors2019-06-03
K150349 — Rapid Hair Removal Pads2015-07-14
K140502 — ZOLL E SERIES ALS2014-11-06

More clearances from Zmi Corp.

view all

K915100 — BRINDLEY & SMITH ET-10001992-09-14
K915159 — PEDIATRIC MULTI-FUNCTION ELECTRODES1992-02-07
K913484 — ZOLL D-900 DEFIBRILLATOR1991-12-16
K911956 — ZOLL PD-1400 PACER/DEFIBRILLATOR1991-07-31
K885166 — ZMI PART NO. NTP-2100, PEDIATRIC ELECTRODES1989-05-01

Adverse events under product code LDD

product code LDD

Death: 38
Malfunction: 522
Total: 560

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.