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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Holter 1810/ 2010 SW
Classification Name: ELECTROCARDIOGRAPH, AMBULATORY, WITH ANALYSIS ALGORITHM
Product Code: MLO
Device Class: 2
Regulation Number: 870.2800
Medical Specialty: Cardiovascular
Registered Establishment Name: Philips North America LLC
Registered Establishment Number: 1218950
Premarket Submission Number: K010949
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Specification Developer
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