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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: C5-1; C6-2; C9-3v; C9-4v; CX50 Diagnostic Ultrasound System; D5cwc; L12-3; L12-4; S4-2; S5-1; Sparq Diagnostic Ultrasound System; 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: K091804
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Foreign Exporter
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