Magnet, Test, Pacemaker

Device Code: 785

Product Code(s): DTG

Device Classification Information

Device Type ID785
Device NameMagnet, Test, Pacemaker
Regulation DescriptionPacemaker Test Magnet.
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 Number870.3690 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeDTG
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID785
DeviceMagnet, Test, Pacemaker
Product CodeDTG
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionPacemaker Test Magnet.
CFR Regulation Number870.3690 [🔎]
Device Problems
Accessory Incompatible
1
High Capture Threshold
1
Total Device Problems 2
TPLC Last Update: 2019-04-02 19:41:29

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