DTA · Class II · 21 CFR 870.3720

FDA Product Code DTA: Tester, Pacemaker Electrode Function

Leading manufacturers include Biotronik, Inc., Medtronic, Inc. and Cardiac Pacemakers, Inc..

10
Total
10
Cleared
95d
Avg days
1979
Since

FDA 510(k) Cleared Tester, Pacemaker Electrode Function Devices (Product Code DTA)

10 devices
1–10 of 10
Cleared Feb 28, 2017
CareLink SmartSync Device Manager - Pacing System Analyzer
K163008
Medtronic, Inc.
Cardiovascular · 123d
Cleared Dec 20, 2007
MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS
K073230
Biotronik, Inc.
Cardiovascular · 35d
Cleared Dec 08, 2003
MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER
K033613
Biotronik, Inc.
Cardiovascular · 21d
Cleared Jan 27, 2003
ERA 3000
K022360
Biotronik, Inc.
Cardiovascular · 192d
Cleared Dec 02, 1981
SIEMENS-ELEMA PSA 376
K812104
Siemens Corp.
Cardiovascular · 131d
Cleared May 17, 1979
CARDIOTEST 2200
K790503
Cardiac Pacemakers, Inc.
Cardiovascular · 65d

About Product Code DTA - Regulatory Context