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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K843920
Device Name FLUOROSCAN/TM BY HEALTHMATE
Applicant
Healthmate, Inc.
3000 Dundee Rd.
Northbrook,  IL  60062 -
Applicant Contact KEN WIESELMAN
Correspondent
Healthmate, Inc.
3000 Dundee Rd.
Northbrook,  IL  60062 -
Correspondent Contact KEN WIESELMAN
Regulation Number892.1650
Classification Product Code
JAA  
Date Received10/05/1984
Decision Date 02/07/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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