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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: 863286, SureSigns VS4 Government Bundle; 989803180831, Genius 2 tympanic temperature probe; 989803192931, SureSigns VS Temporal Temperature HH
Classification Name: ALARM, BLOOD-PRESSURE
Product Code: DSJ
Device Class: 2
Regulation Number: 870.1100
Medical Specialty: Cardiovascular
Registered Establishment Name: Philips Electronics Ltd
Registered Establishment Number: 3000126629
Premarket Submission Number: K151761
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Foreign Exporter
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