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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: 3D6-2; 3D8-4; 3D9-3v; C5-2 (21426A); C8-4 (21437A); C8-5; C9-4; C9-5ec; D2cwc; D2tcd; D5cwc; HD11 Diagnostic Ultrasound System; L12-3; L12-5; L15-7io; L8-4; PA4-2 (21422A); S12-4 (21780A); S3-1 (21711A); S4-2; S7-2omni (21778A); S7-3t (21781A); S8-3 (21750A); T6H (21378A)
Classification Name: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
Product Code: IYN
Device Class: 2
Regulation Number: 892.1550
Medical Specialty: Radiology
Registered Establishment Name: Philips Electronics Ltd
Registered Establishment Number: 3000126629
Premarket Submission Number: K043535
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Foreign Exporter
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