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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: IntelliVue GuardianSoftware
Classification Name: MEDICAL DEVICE DATA SYSTEM
Product Code: OUG
Device Class: 1
Regulation Number: 880.6310
Medical Specialty: General Hospital
Registered Establishment Name: Philips Electronics Ltd
Registered Establishment Number: 3000126629
Premarket Submission Number: K180534
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Foreign Exporter
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