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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: 3D9-3v; C10-4ec; D2cwc; C5-1; C6-2; C8-5; C9-2; C10-3v; D2tcd; D5cwc; eL18-4; eL18-4 EMT; EPIQ 5 Diagnostic Ultrasound System; EPIQ 5C Diagnostic Ultrasound System; EPIQ 5G Diagnostic Ultrasound System; EPIQ 5W Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; EPIQ 7C Diagnostic Ultrasound System; EPIQ 7G Diagnostic Ultrasound System; EPIQ 7W Diagnostic Ultrasound System; EPIQ CVx Diagnostic Ultrasound System; EPIQ CVxi Diagnostic Ultrasound System; EPIQ Diagnostic Ultrasound System; EPIQ Elite Diagnostic Ultrasound System; L12-3; L12-3ERGO; L12-5; L15-7io; L18-5; mC7-2; mC12-3; S4-2; S5-1; S7-3t; S8-3;S8-3t; S9-2; V6-2; V9-2; VL13-5; X5-1; X6-1; X7-2; X7-2t ; X8-2t; XL14-3
Classification Name: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
Product Code: IYO
Device Class: 2
Regulation Number: 892.1560
Medical Specialty: Radiology
Registered Establishment Name: Philips Electronics Ltd
Registered Establishment Number: 3000126629
Premarket Submission Number: K200304
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Foreign Exporter
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