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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: IntelliVue Guardian Software
Classification Name: MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)
Product Code: DRT
Device Class: 2
Regulation Number: 870.2300
Medical Specialty: Cardiovascular
Registered Establishment Name: Philips Electronics Ltd
Registered Establishment Number: 3000126629
Premarket Submission Number: K111905
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Foreign Exporter
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