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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: 2-CH Patch; 40494E, Limb Clamp Electrode; BTP-1000P (Patch); ePatch ECG Electrode; ePatch electrode; MCOT Patch; Neonatal Quadtrode MRI ECG Electrode Pad - 989803179051; Patch; Patch ECG Electrode; Patch electrode; Quadtrode CV MRI ECG Electrode Pad - 989803179041; QUADTRODE MRI ECG PAD,25/BOX - 989803179031; Universal Patch
Classification Name: ELECTRODE, ELECTROCARDIOGRAPH
Product Code: DRX
Device Class: 2
Regulation Number: 870.2360
Medical Specialty: Cardiovascular
Registered Establishment Name: Philips North America LLC
Registered Establishment Number: 1218950
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Specification Developer
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