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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 K873599
Device Name EDI 320
Applicant
Cybex
2100 Smithtown Ave.
P.O. Box 9003
Ronkonkoma,  NY  11779
Applicant Contact WILLIAM SAUER
Correspondent
Cybex
2100 Smithtown Ave.
P.O. Box 9003
Ronkonkoma,  NY  11779
Correspondent Contact WILLIAM SAUER
Regulation Number888.1500
Classification Product Code
KQX  
Date Received09/04/1987
Decision Date 10/16/1987
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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