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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Goniometer, Ac-Powered
510(k) Number K893903
Device Name KRONAMAX KUBE
Applicant
Physicians Digital Co.
12600 San Pablo Ave.
Suite A
Richmond,  CA  94805
Applicant Contact DAVID R SCHULTZ
Correspondent
Physicians Digital Co.
12600 San Pablo Ave.
Suite A
Richmond,  CA  94805
Correspondent Contact DAVID R SCHULTZ
Regulation Number888.1500
Classification Product Code
KQX  
Date Received05/30/1989
Decision Date 11/29/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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