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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Digital Image Storage, Radiological
510(k) Number K882184
Device Name HR-1000 W/SUFFIXES (B,C OR D)
Applicant
Eigen
P.O. Box 848
Nevada City,  CA  95959
Applicant Contact MARK A HOFFMAN
Correspondent
Eigen
P.O. Box 848
Nevada City,  CA  95959
Correspondent Contact MARK A HOFFMAN
Regulation Number892.2010
Classification Product Code
LMB  
Date Received05/24/1988
Decision Date 06/28/1988
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
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