Electrocardiograph, Ambulatory, With Analysis Algorithm

Device Code: 881

Product Code(s): MLO

Device Classification Information

• Device Type ID: 881
• Device Name: Electrocardiograph, Ambulatory, With Analysis Algorithm
• Regulation Description: Medical Magnetic Tape Recorder.
• 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: 870.2800 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: MLO
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 3-118 AAMI ANSI EC57:2012
  Testing And Reporting Performance Results Of Cardiac Rhythm And ST-segment Measurement Algorithms
• 3-127 AAMI ANSI IEC 60601-2-47:2012/(R)2016
  Medical Electrical Equipment -- Part 2-47: Particular Requirements For The Basic Safety And Essential Performance Of Ambulatory Electrocardiographic Systems
• 3-129 AAMI ANSI EC53:2013
  ECG Trunk Cables And Patient Leadwires
• 3-155 IEC 60601-2-47 Edition 2.0 2012-02
  Medical Electrical Equipment - Part 2-47: Particular Requirements For The Basic Safety And Essential Performanceof Ambulatory Electrocardiographic Systems

Total Product Life Cycle

• Device Type ID: 881
• Device: Electrocardiograph, Ambulatory, With Analysis Algorithm
• Product Code: MLO
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Medical Magnetic Tape Recorder.
• CFR Regulation Number: 870.2800 [🔎]

Premarket Reviews
Manufacturer	Decision
BITTIUM BIOSIGNALS LTD.
	SUBSTANTIALLY EQUIVALENT	1
LABTECH KFT.
	SUBSTANTIALLY EQUIVALENT	1

TPLC Last Update: 2019-04-02 19:44:20