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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: 3D9-3v; BP10-5ec; C5-2; C6-3; C8-4v; C8-5; D2cwc; D5cwc; HD15 Diagnostic Ultrasound System; L12-3; L12-5; L15-7io; L9-3; S12-4; S5-2; S7-2omnni; S8-3; V6-2
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: K081661
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Foreign Exporter
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