MONITOR ULTRASOUND MANUFACTURED BY VIASYS NEUROCARE

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Request for Information Form	Contact Information
Company Name	VIASYS NEUROCARE
Address	5225 VERONA RD.
City, State, Zip	MADISON, WI 53711
Country	US
FDA Owner/Operator Phone	610-862-0800
FDA Medical Specialty Code	OB - Obstetrics/Gynecology
FDA Product Code	HEK
FDA Classification Name	MONITOR, HEART SOUND, FETAL, ULTRASONIC
FDA Device Classification Code	Standards
FDA Regulation Number	884.2660
FDA Common Generic Name	MONITOR
FDA Proprietary Device Name	MONITOR ULTRASOUND
FDA Owner / Operator Number	9048965
FDA Owner / Operator Name	VIASYS HEALTHCARE, INC.
FDA Establishment Registration Number	2126317
FDA Registered Establishment Name	VIASYS NEUROCARE
FDA Operation Code(s)	MM - Manufacturer MR - Remanufacturer MS - Specification Developer
FDA Listing Date	06-14-02
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	INTERMED CO., LTD. 163-5 SEO HEUNG BLDG., 5TH FL. POI-DONG, KANGNAM-KU SEOUL, KS 822-573-9084 / 305-477-8886	IFM-500	FETAL MONITOR
2	SEWARD LTD. ROMAN WAY, FISON WAY INDUSTRIAL ESTATE THETFORD, NORFOLK, IP24 1XB UK 020-836-5 4100x108 / 018-427-54706	MULTIPLE	VARIOUS MODELS OF FETAL DOPPLERS
3	ZETEK, INC. 876 VENTURA ST. AURORA, CO 80011 US 303-343-2122 / 303-343-2122	NO PROPRIETARY NAME LISTED	NO COMMON NAME LISTED