Tools, Pacemaker Service

Device Code: 784

Product Code(s): DTF

Device Classification Information

Device Type ID784
Device NameTools, Pacemaker Service
Regulation DescriptionPacemaker Service Tools.
Regulation Medical SpecialtyCardiovascular
Review PanelCardiovascular
Premarket Review Office Of Device Evaluation (ODE)
Division Of Cardiovascular Devices (DCD)
Implantable Electrophysical Devices Branch (IEDB)
Submission Type510(K) Exempt
CFR Regulation Number870.3730 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeDTF
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID784
DeviceTools, Pacemaker Service
Product CodeDTF
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionPacemaker Service Tools.
CFR Regulation Number870.3730 [🔎]
TPLC Last Update: 2019-04-02 19:41:28

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