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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: CBL OR 3-Lead ECG Trunk Cable, AAMI/IEC - 989803170171; CBL OR 5-Lead ECG Trunk Cable, AAMI/IEC - 989803170181
Classification Name: ELECTROCARDIOGRAPH
Product Code: DPS
Device Class: 2
Regulation Number: 870.2340
Medical Specialty: Cardiovascular
Registered Establishment Name: Philips North America LLC
Registered Establishment Number: 1218950
Premarket Submission Number: K973437
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Specification Developer
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