Cleared Traditional

DP-700 NIKMAN DEFIB-PADS

K872793 · Nikomed U.S.A., Inc. · Cardiovascular
Oct 1987
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K872793 is an FDA 510(k) clearance for the DP-700 NIKMAN DEFIB-PADS, a Dc-defibrillator, Low-energy, (including Paddles) (Class II — Special Controls, product code LDD), submitted by Nikomed U.S.A., Inc. (Belle Mead, US). The FDA issued a Cleared decision on October 9, 1987, 87 days after receiving the submission on July 14, 1987. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5300.

Submission Details

510(k) Number K872793 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 1987
Decision Date October 09, 1987
Days to Decision 87 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code LDD — Dc-defibrillator, Low-energy, (including Paddles)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5300

Similar Devices — LDD Dc-defibrillator, Low-energy, (including Paddles)

All 165
Switched Internal Paddles
K203231 · Philips North America, LLC · Jan 2021
Tempus LS - Manual
K200849 · Remote Diagnostic Technologies, Ltd. A Philips Company · Jul 2020
Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors
K182503 · Physio-Control, Inc. · Jun 2019
Rapid Hair Removal Pads
K150349 · Full Power Aed · Jul 2015
ZOLL E SERIES ALS
K140502 · ZOLL Medical Corporation · Nov 2014
CARDIOMED
K103651 · Cardio Medical Products, Inc. · Oct 2011