GASTROTRAC; POLYGRAM ELECTROGASTROGRAPHY APPLIC SOFWARE MANUFACTURED BY ALPINE BIOMED APS

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Request for Information Form	Contact Information
Company Name	ALPINE BIOMED APS
Address	16-18 TONSBAKKEN
City, State, Zip	SKOVLUNDE,
Country	DA
FDA Owner/Operator Phone	45-44-579000
FDA Medical Specialty Code	GU - Gastroenterology/Urology
FDA Product Code	MYE
FDA Classification Name	SYSTEM,ELECTROGASTROGRAPHY(EGG)
FDA Device Classification Code	Standards
FDA Regulation Number	876.1735
FDA Common Generic Name	ELECTROGASTROGRAPHY SYSTEM
FDA Proprietary Device Name	GASTROTRAC; POLYGRAM ELECTROGASTROGRAPHY APPLIC SOFWARE
FDA Owner / Operator Number	9104580
FDA Owner / Operator Name	ALPINE BIOMED APS
FDA Establishment Registration Number	3004827015
FDA Registered Establishment Name	ALPINE BIOMED APS
FDA Operation Code(s)	MM - Manufacturer MS - Specification Developer
FDA Listing Date	07-10-07
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Our records indicate that the following medical device companies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	3CPM CO., INC. 7402 YORK RD., #100 TOWSON, MD 21204 US 775-833-0128 / 202-885-5548	3CPM EGG MACHINE	ELECTROGASTROGRAPHY SYSTEM
2	MEDTRONIC NEUROMODULATION 4000 LEXINGTON AVENUE SHOREVIEW, MN 55126 US 763-514-4000 / 763-505-0874	POLYGRAF ID WITH POLYGRAM NET ELECTROGASTROGRAPHY (EGG) APPLICATION SOFTWARE	VARIOUS TYPES OF ELECTROGASTROGRAPHY (EGG) SYSTEMS