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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: 989803163181 Mobile CL Disposable Small Adult Cuff; 989803163191 Mobile CL Reusable Adult Cuff; 989803163201 Mobile CL Disposable Adult Cuff; 989803163211 Mobile CL Reusable Large Adult Cuff; 989803163221 Mobile CL Disposable Large Adult Cuff; 989803163251 Mobile CL NBP Cradle Kit; 989803168881 Mobile CL Transmitter Cradles; Diverse Specialized Accessories and IntelliVue CL 865220 charging station; IntelliVue CL SpO2 Pod, CL NBP Pod SW Rev. A.0; IntelliVue Multi-Measurement Module X2, SW Rev. H.01; IntelliVue Patient Monitor MP5, MP5T, MP2, SW Rev. H.01; IntelliVue Telemetry System Transceiver TRx4841A, SW Rev. D.0
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 Electronics Ltd
Registered Establishment Number: 3000126629
Premarket Submission Number: K101600
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Foreign Exporter
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