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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: 989803172031 SPU ECG Lead Set, 5 Lead, AAMI, Grabber; 989803172051 ECG 5 lead Graber, AAMI + SpO2, SPU, Tele; 989803172131 SPU ECG Lead Set, 5 Lead, AAMI, Grabber; 989803172151 ECG 5 lead Grabber, IEC + SpO2,SPU,Tele; 989803172221 ECG 5L Grabber, AAMI, SpO2, Tele; Intellivue MX40 Patient Monitor
Classification Name: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
Product Code: MHX
Device Class: 2
Regulation Number: 870.1025
Medical Specialty: Cardiovascular
Registered Establishment Name: Philips North America LLC
Registered Establishment Number: 1218950
Premarket Submission Number: K113125
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Specification Developer
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