DRO · Class II · 21 CFR 870.5550

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

Leading manufacturers include Medtronic Vascular and Hewlett-Packard Co..

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 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 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

About Product Code DRO - Regulatory Context