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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: 989803173121 3-Lead Set, Single Patient Use Disposable, Bedside, AAMI; 989803173131 5-Lead Set, Single Patient Use Disposable, Bedside, AAMI; 989803173151 5-Lead Set, Single Patient Use Disposable,Telemetry, AAMI; 989803174201 3-Lead Set, Single Patient Use Disposable, Bedside, IEC; 989803174211 5-Lead Set, Single Patient Use Disposable,Bedside, IEC; 989803192141 5-Lead Set, Single Patient Use Disposable, Chest, AAMI; 989803192151 5-Lead Set, Single Patient Use Disposable, Chest, IEC; 989803197511 6-Lead Set, Patient Use Disposable, Bedside, AAMI; 989803197521 6-Lead Set, Single Patient Use Disposable, Bedside, IEC
Classification Name: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
Product Code: DSA
Device Class: 2
Regulation Number: 870.2900
Medical Specialty: Cardiovascular
Registered Establishment Name: Philips Electronics Ltd
Registered Establishment Number: 3000126629
Premarket Submission Number: K110287
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Foreign Exporter
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