DRO · Class II · 21 CFR 870.5550

FDA Product Code DRO: Pacemaker, Cardiac, External Transcutaneous (non-invasive)

Leading manufacturers include Physio-Control Corp., Medtronic Vascular and Conmedcorp.

84
Total
84
Cleared
105d
Avg days
1982
Since

FDA 510(k) Cleared Pacemaker, Cardiac, External Transcutaneous (non-invasive) Devices (Product Code DRO)

84 devices
1–24 of 84
Cleared Mar 06, 1997
CARDIOSERV P
K962547
Marquette Electronics, Inc.
Cardiovascular · 251d
Cleared Feb 28, 1997
RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM
K963120
Marquette Electronics, Inc.
Cardiovascular · 200d
Cleared Dec 29, 1995
LIFEPAK 11
K951593
Physio-Control Corp.
Cardiovascular · 267d
Cleared May 22, 1995
HEWLETT PACKARD M2475B CODEMASTER 100 DEFIBRILLATOR/MONITOR
K950483
Hewlett-Packard Co.
Cardiovascular · 108d
Cleared Jul 30, 1992
MODELS M1722A, M1723A, M1724A DEFIBRILLATORS
K915757
Hewlett-Packard Co.
Cardiovascular · 220d
Cleared Sep 11, 1991
QUIK-PACE(R) OR EX-PACE(TM) PEDIATRIC PACING ELEC
K912599
Physio-Control Corp.
Cardiovascular · 93d
Cleared Dec 20, 1989
NKA MODEL SEC-3102 CARDIAC STIMULATOR
K894492
Nihon Kohden America, Inc.
Cardiovascular · 155d
Cleared Oct 26, 1989
DEFIB/PACING PADS
K894588
Conmedcorp
Cardiovascular · 94d
Cleared Sep 20, 1988
QUIK-PACE II ELECTRODES
K883121
Physio-Control Corp.
Cardiovascular · 56d
Cleared Dec 29, 1987
QUIK-PACE NONINVASIVE PACEMAKER
K871751
Physio-Control Corp.
Cardiovascular · 235d
Cleared Sep 18, 1987
MODIFIED VERSA STIM ELECTRODE LINE
K872368
Conmedcorp
Cardiovascular · 92d
Cleared Oct 31, 1986
MEDTRONIC MODEL 5455 DISPOSABLE SURGICAL CABLE
K863547
Medtronic Vascular
Cardiovascular · 49d
Cleared Jul 11, 1986
ALTERNATE SIZE E-Z-PACE ELECTRODE
K862298
Medtronic Vascular
Cardiovascular · 24d
Cleared Jan 13, 1986
AMENDMENT LIFEPAK 8, NPN 052
K854117
Physio-Control Corp.
Cardiovascular · 96d
Cleared Dec 09, 1985
LIFEPAK 8 MODIFICATION
K853732
Physio-Control Corp.
Cardiovascular · 94d
Cleared Apr 19, 1985
AMENDMENT LIFEPAK 200, NPN 046
K851247
Physio-Control Corp.
Cardiovascular · 43d
Cleared Apr 19, 1985
AMENDMENT LIFEPAK 100, NPN 045
K851248
Physio-Control Corp.
Cardiovascular · 43d
Cleared Feb 04, 1984
LIFEPAK 7D
K840047
Physio-Control Corp.
Cardiovascular · 29d
Cleared Jan 30, 1984
LIFEPAK 7P
K832876
Physio-Control Corp.
Cardiovascular · 157d

About Product Code DRO - Regulatory Context