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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: 989803171811 ECG 3 lead Grabber, AAMI + SpO2, Tele; 989803171821 ECG 5 lead Snaps, AAMI, Tele; 989803171831 ECG 5 lead Grabber, AAMI, Tele; 989803171841 ECG 5 lead Snaps, AAMI + SpO2, Tele; 989803171851 ECG 5 lead Grabber, AAMI + SpO2, Tele; 989803171861 ECG 6 lead Grabber, AAMI, Tele; 989803171911 ECG 3 lead Grabber, IEC + SpO2, Tele; 989803171931 ECG 5 lead Grabber, IEC, Tele; 989803171951 ECG 5 lead Grabber, IEC + SpO2, Tele; 989803171961 ECG 6 lead Grabber, IEC, Tele; 989803171971 CBL ECG 6 Lead Grabber, IEC+SpO2, Tele; 989803199071 ECG 6 lead Grabber, IEC + SpO2, Tele; 989803199081 MX40 Adapter SpO2-only; 989803199091 MX40 Adapter 5L+SpO2; 989803199101 MX40 Adapter 3L+SpO2; 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: K103646
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Specification Developer
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