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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: PageWriter TC30 Cardiograph, TC30 (860306); PageWriter TC50 Cardiograph, TC50 (860310, 860429, 860466); PageWriter TC70 Cardiograph, TC70 (860315, 860352)
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: K210560
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Specification Developer
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