Auxiliary Power Supply (acor Dc) For External Transcutaneous Cardiac Pacemaker

Device Code: 887

Product Code(s): MPE

Device Classification Information

• Device Type ID: 887
• Device Name: Auxiliary Power Supply (acor Dc) For External Transcutaneous Cardiac Pacemaker
• Regulation Description: External Transcutaneous Cardiac Pacemaker (noninvasive).
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Cardiovascular Devices (DCD); Implantable Electrophysical Devices Branch (IEDB)
• Submission Type: 510(k)
• CFR Regulation Number: 870.5550 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: MPE
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: Yes
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 887
• Device: Auxiliary Power Supply (acor Dc) For External Transcutaneous Cardiac Pacemaker
• Product Code: MPE
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: External Transcutaneous Cardiac Pacemaker (noninvasive).
• CFR Regulation Number: 870.5550 [🔎]

TPLC Last Update: 2019-04-02 19:44:24