Auxiliary Power Supply (ac Or Dc) For Low-energy Dc-defibrillator

Device Code: 886

Product Code(s): MPD

Device Classification Information

Device Type ID886
Device NameAuxiliary Power Supply (ac Or Dc) For Low-energy Dc-defibrillator
Regulation DescriptionDC-defibrillator (including Paddles).
Regulation Medical SpecialtyCardiovascular
Review PanelCardiovascular
Premarket Review Office Of Device Evaluation (ODE)
Division Of Cardiovascular Devices (DCD)
Cardiac Diagnostics Devices Branch (CDDB)
Submission Type510(k)
CFR Regulation Number870.5300 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeMPD
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceYes
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID886
DeviceAuxiliary Power Supply (ac Or Dc) For Low-energy Dc-defibrillator
Product CodeMPD
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionDC-defibrillator (including Paddles).
CFR Regulation Number870.5300 [🔎]
TPLC Last Update: 2019-04-02 19:44:23

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