Electrocardiograph, Ambulatory (without Analysis)

Device Code: 892

Product Code(s): MWJ

Device Classification Information

• Device Type ID: 892
• Device Name: Electrocardiograph, Ambulatory (without Analysis)
• 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: MWJ
• 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: 892
• Device: Electrocardiograph, Ambulatory (without Analysis)
• Product Code: MWJ
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Medical Magnetic Tape Recorder.
• CFR Regulation Number: 870.2800 [🔎]

Premarket Reviews
Manufacturer	Decision
DIAGNOSTIC MONITORING SOFTWARE
	SUBSTANTIALLY EQUIVALENT	1
MORTARA INSTRUMENT, INC
	SUBSTANTIALLY EQUIVALENT	1
NORAV MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
NORTH EAST MONITORING INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Leak / Splash	1
Fluid Leak	1
Total Device Problems	2

TPLC Last Update: 2019-04-02 19:44:29