DRL · Class II · 21 CFR 870.5325

FDA Product Code DRL: Tester, Defibrillator

Leading manufacturers include Bio-Tek Instruments, Inc., Seaward Group and Netech Corporation.

19
Total
19
Cleared
119d
Avg days
1978
Since

FDA 510(k) Cleared Tester, Defibrillator Devices (Product Code DRL)

19 devices
1–19 of 19
Cleared Aug 28, 2019
Delta 3300
K190437
Netech Corporation
Cardiovascular · 187d
Cleared Dec 14, 2018
UniPulse
K182905
Seaward Group
Cardiovascular · 59d
Cleared Nov 17, 1995
MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER
K954391
Bio-Tek Instruments, Inc.
Cardiovascular · 59d
Cleared Mar 18, 1991
DEFIBRILLATOR ANALYZER MODEL QED-5
K904159
Bio-Tek Instruments, Inc.
Cardiovascular · 188d
Cleared Mar 23, 1979
DEFIBRILLATOR INTERAL PADDLE TEST LOAD
K790394
Physio-Control Corp.
Cardiovascular · 25d
Cleared Dec 15, 1978
CARDIAC CARE Q/C TEST KIT
K782033
Instrumentation Laboratory CO
Cardiovascular · 9d

About Product Code DRL - Regulatory Context