LDD · Class II · 21 CFR 870.5300

FDA Product Code LDD: Dc-defibrillator, Low-energy, (including Paddles)

Leading manufacturers include Hewlett-Packard Co., Physio-Control, Inc. and Remote Diagnostic Technologies, Ltd. A Philips Company.

166
Total
166
Cleared
120d
Avg days
1978
Since

FDA 510(k) Cleared Dc-defibrillator, Low-energy, (including Paddles) Devices (Product Code LDD)

166 devices
1–24 of 166
Cleared Jan 11, 2021
Switched Internal Paddles
K203231
Philips North America, LLC
Cardiovascular · 70d
Cleared Jul 24, 2020
Tempus LS - Manual
K200849
Remote Diagnostic Technologies, Ltd. A Philips Company
Cardiovascular · 115d
Cleared Jun 03, 2019
Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors
K182503
Physio-Control, Inc.
Cardiovascular · 264d
Cleared May 08, 1991
MODEL 43100A SERIES DEFIBRILLATOR, MODIFICATION
K910754
Hewlett-Packard Co.
Cardiovascular · 86d
Cleared Aug 03, 1989
MODELS HP 43110MC, 43200MC W/CASE & 43200M NO CASE
K893403
Hewlett-Packard Co.
Cardiovascular · 94d
Cleared Oct 11, 1985
MODEL 43130A DEFIBRILLATOR
K853439
Hewlett-Packard Co.
Cardiovascular · 56d
Cleared Feb 12, 1985
MODELS 43100A, 43110A & 43120A DEFIBRILLATOR/MONIT
K844740
Hewlett-Packard Co.
Cardiovascular · 69d
Cleared Mar 17, 1983
THERACARD 400
K823828
Siemens Medical Solutions USA, Inc.
Cardiovascular · 87d
Cleared Jan 26, 1983
MODEL 78670A
K823268
Hewlett-Packard Co.
Cardiovascular · 85d
Cleared Sep 21, 1981
DEFIBRILLATOR/MONITOR
K812317
Hewlett-Packard Co.
Cardiovascular · 35d

About Product Code LDD - Regulatory Context