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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Avalon Basestation (866074); Avalon CL Fetal & Maternal Pod (866488); Avalon Fetal & Maternal Patch; Avalon Fetal/Maternal Monitors FM20 (M2702A), FM30 (M2703A), FM40 (M2704A) and FM50 (M2705A); Avalon Patient Module (M2738A); M2734B; MECG Adapter Cable (M1363A); Remote Event Marker (989803143411); Transducers (866075, 866076, 866077, 867245, 867246, 867247, 867248, 867249, M2735A, M2736A, M2736AA)
Classification Name: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Product Code: DXN
Device Class: 2
Regulation Number: 870.1130
Medical Specialty: Cardiovascular
Registered Establishment Name: Philips North America LLC
Registered Establishment Number: 1218950
Premarket Submission Number: K140535
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Specification Developer
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