Tester, Electrode, Surface, Electrocardiographic

Device Code: 850

Product Code(s): KRC

Device Classification Information

• Device Type ID: 850
• Device Name: Tester, Electrode, Surface, Electrocardiographic
• Regulation Description: Electrocardiograph Surface Electrode Tester.
• 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: 510(k)
• CFR Regulation Number: 870.2370 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: KRC
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

• Device Type ID: 850
• Device: Tester, Electrode, Surface, Electrocardiographic
• Product Code: KRC
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Electrocardiograph Surface Electrode Tester.
• CFR Regulation Number: 870.2370 [🔎]

TPLC Last Update: 2019-04-02 19:43:24