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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: 989803148821 Radiolucent Foam Electrode
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
Premarket Submission Number: K953649
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Repackager/Relabeler
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