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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: DigiTrak XT Holter Recorder w/Leadwires; DigiTrak XT Recorder; DL800 Holter System; DL950 Holter System
Classification Name: ELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS)
Product Code: MWJ
Device Class: 2
Regulation Number: 870.2800
Medical Specialty: Cardiovascular
Registered Establishment Name: Philips North America LLC
Registered Establishment Number: 1218950
Premarket Submission Number: K071733
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Specification Developer
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