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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: 3D9-3v; C10-3v; C5-2; C8-4v; C8-5; C9-4; C9-5ec; D2 CW; D2 TC; D2cwc; D2tcd; D5cwc; iE33 Diagnostic Ultrasound System; iU22 Diagnostic Ultrasound System; L11-3; L12-5 38mm; L12-5 50mm; L15-7io; L17-5; L8-4; L9-3; L9-5 LAP; S12-4; S3-1; S4-1; S7-2omni; S7-3t; S8-3; S8-3t; T6207; T6H; V6-2; VL13-5; X5-1; X6-1; X7-2; X7-2t
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: K030455
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Foreign Exporter
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