DRO · Class II · 21 CFR 870.5550

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

Leading manufacturers include Cardiac Resucitator Corp., Physio-Control Corp. and Cardiotronics, Inc..

84
Total
84
Cleared
105d
Avg days
1982
Since
84 devices
25–48 of 84
Cleared Nov 09, 1988
TRAID-EP, PLATE INPUT, W/PULSE BLANKING CIRCUITRY
K883304
Cardiotronics, Inc.
Cardiovascular · 98d
Cleared Oct 06, 1988
TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE, W/PULSE
K883523
Cardiotronics, Inc.
Cardiovascular · 50d
Cleared Sep 20, 1988
QUIK-PACE II ELECTRODES
K883121
Physio-Control Corp.
Cardiovascular · 56d
Cleared Aug 30, 1988
MODEL #716 ADULT STIM. PADS LOW IMPEDANCE GEL TYPE
K882338
Cardiotronics, Inc.
Cardiovascular · 85d
Cleared Aug 30, 1988
MODEL #918 MULTI-PADS
K883375
Cardiotronics, Inc.
Cardiovascular · 21d
Cleared Jul 18, 1988
TRIAD-EP
K880936
Cardiotronics, Inc.
Cardiovascular · 133d
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 Jun 29, 1987
LECTEC NON-INVASIVE PACING ELECTRODE
K872012
Lectec Corp.
Cardiovascular · 34d
Cleared Jun 24, 1987
STAT-PAD (TM)
K871538
Cardiac Resucitator Corp.
Cardiovascular · 65d
Cleared Jun 24, 1987
MODIFIED PACE*AID MODEL 53
K871971
Cardiac Resucitator Corp.
Cardiovascular · 34d
Cleared Jun 08, 1987
MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR
K871569
Cardiac Resucitator Corp.
Cardiovascular · 45d
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 Mar 31, 1986
AMI CARDIO-PAD
K860283
Andover Medical, Inc.
Cardiovascular · 62d
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 Nov 05, 1985
EMERGIPACE - EXTERNAL PACEMAKER
K850812
Life Science Instrumentation, Inc.
Cardiovascular · 250d
Cleared Oct 11, 1985
PACEPAC
K852958
Medical Data Electronics
Cardiovascular · 91d
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 Mar 06, 1985
PACE*AID 10 A -PAD 10A- PACEMAKER OUTPUT DISPLAY &
K850596
Cardiac Resucitator Corp.
Cardiovascular · 19d
Cleared Feb 14, 1985
HEART AID MODEL 97
K850170
Cardiac Resucitator Corp.
Cardiovascular · 29d
Cleared Jan 24, 1985
PACE AID MODEL 53
K844811
Cardiac Resucitator Corp.
Cardiovascular · 44d