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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: IntelliVue CL Respiration Pod, SW Rev. B.0; IntelliVue GuardianSoftware SW Rev. A.02; IntelliVue Multi-Measurement Module X2, SW Rev. J.07; IntelliVue Patient Monitor MP2, SW Rev. J.07; IntelliVue Patient Monitor MP5, MP5T, MP5SC, SW Rev. J.07; Mobile CL Respiration Pod Attachment
Classification Name: DETECTOR AND ALARM, ARRHYTHMIA
Product Code: DSI
Device Class: 2
Regulation Number: 870.1025
Medical Specialty: Cardiovascular
Registered Establishment Name: Philips Electronics Ltd
Registered Establishment Number: 3000126629
Premarket Submission Number: K150310
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Foreign Exporter
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