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
49–72 of 84
Cleared Dec 17, 1984
PACE *AID MODEL 52
K843547
Cardiac Resucitator Corp.
Cardiovascular · 98d
Cleared Nov 19, 1984
HEART-AID MODEL 80
K843358
Cardiac Resucitator Corp.
Cardiovascular · 84d
Cleared Feb 04, 1984
LIFEPAK 7D
K840047
Physio-Control Corp.
Cardiovascular · 29d
Cleared Jan 30, 1984
LIFEPAK 7P
K832876
Physio-Control Corp.
Cardiovascular · 157d
Cleared Aug 06, 1982
PACE* AID MODEL 50
K820507
Cardiac Resucitator Corp.
Cardiovascular · 162d
Cleared Aug 06, 1982
HEART *AID, #80
K820609
Cardiac Resucitator Corp.
Cardiovascular · 151d
Cleared Aug 06, 1982
HEART AID #90
K821152
Cardiac Resucitator Corp.
Cardiovascular · 102d
Cleared Aug 06, 1982
HEART*AID, ALS, MODEL 95
K821673
Cardiac Resucitator Corp.
Cardiovascular · 60d
Cleared Jan 18, 1982
PACE *AID
K813553
Cardiac Resucitator Corp.
Cardiovascular · 27d