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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: 989803156201 Adult Disposable Metallic 3 Leadwire Electrode Set, AAMI; 989803156221 Adult Disposable Radiolucent 3 Leadwire Electrode Set, AAMI; 989803156231 Adult Disposable Radiolucent 3 Leadwire Electrode Set, IEC; 989803156241 Adult Disposable Metallic 5 Leadwire Electrode Set, AAMI; 989803156261 Adult Disposable Radiolucent 5 Leadwire Electrode Set, AAMI; 989803156271 Adult Disp Radiolucent 5 Leadwire Electrode Set, IEC
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: K080106
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Repackager/Relabeler
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