Dc-defibrillator, High Energy, (including Paddles)

Device Code: 750

Product Code(s): DRK

Definition: PMA To Be Filed By 12/26/96 (FR 50706 (9/27/96))

Device Classification Information

• Device Type ID: 750
• Device Name: Dc-defibrillator, High Energy, (including Paddles)
• Regulation Description: DC-defibrillator (including Paddles).
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Cardiovascular Devices (DCD); Cardiac Diagnostics Devices Branch (CDDB)
• Submission Type: PMA
• CFR Regulation Number: 870.5300 [🔎]
• FDA Device Classification: Class 3 Medical Device
• Product Code: DRK
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 3-129 AAMI ANSI EC53:2013
  ECG Trunk Cables And Patient Leadwires

Total Product Life Cycle

• Device Type ID: 750
• Device: Dc-defibrillator, High Energy, (including Paddles)
• Product Code: DRK
• FDA Device Classification: Class 3 Medical Device
• Regulation Description: DC-defibrillator (including Paddles).
• CFR Regulation Number: 870.5300 [🔎]

Device Problems
Defibrillation Problem	1
Total Device Problems	1

TPLC Last Update: 2019-04-02 19:40:32