Monitor, St Segment

Device Code: 878

Product Code(s): MLC

Device Classification Information

• Device Type ID: 878
• Device Name: Monitor, St Segment
• Regulation Description: Electrocardiograph.
• 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: 870.2340 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: MLC
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

• 3-118 AAMI ANSI EC57:2012
  Testing And Reporting Performance Results Of Cardiac Rhythm And ST-segment Measurement Algorithms
• 3-129 AAMI ANSI EC53:2013
  ECG Trunk Cables And Patient Leadwires
• 13-56 IEEE Std 11073-10406-2011
  Health Informatics - Personal Health Device Communication Part 10406: Device Specialization - Basic Electrocardiograph
• 13-75 IEEE ISO 11073-10102 First Edition 2014-03-01
  Health Informatics - Point-of-care Medical Device Communication - Part 10102: Nomenclature - Annotated ECG
• 13-76 ISO 11073-91064 First Edition 2009-05-01
  Health Informatics - Standard Communication Protocol - Computer-assisted Electrocardiography
• 13-89 IEEE ISO 11073-10406 First Edition 2012-12-01
  Health Informatics - Personal Health Device Communication - Part 10406: Device Specialization - Basic Electrocardiograph (ECG) (1- To 3-lead ECG)

Total Product Life Cycle

• Device Type ID: 878
• Device: Monitor, St Segment
• Product Code: MLC
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Electrocardiograph.
• CFR Regulation Number: 870.2340 [🔎]

TPLC Last Update: 2019-04-02 19:44:17