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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Image-Intensified Fluoroscopic X-Ray System, Mobile
510(k) Number K911739
Device Name SWEMAC REISON BIPLANAR 300
Applicant
Seemac Reison AB Co.
Industrigatan 11
S-582 31 Linkoping,
Sweden,  SE
Applicant Contact TORE NORMANN
Correspondent
Seemac Reison AB Co.
Industrigatan 11
S-582 31 Linkoping,
Sweden,  SE
Correspondent Contact TORE NORMANN
Regulation Number892.1650
Classification Product Code
OXO  
Date Received04/17/1991
Decision Date 10/23/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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