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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flowmeter, Blood, Cardiovascular
510(k) Number K904317
Device Name AVALON GENERAL PURPOSE SCANNER, PREVIEW GP
Applicant
Avalon Technology Corp.
9174 Castlegate Dr.
Indianapolis,  IN  46256
Applicant Contact WILLIAM D LIPPS
Correspondent
Avalon Technology Corp.
9174 Castlegate Dr.
Indianapolis,  IN  46256
Correspondent Contact WILLIAM D LIPPS
Regulation Number870.2100
Classification Product Code
DPW  
Date Received09/20/1990
Decision Date 02/13/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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