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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 K943898
Device Name SAUNDERS ELECTRONIC INCLINOMETER
Applicant
The Saunders Group
4250 Norex Dr.
Chaska,  MN  55318
Applicant Contact T.L. MILLS
Correspondent
The Saunders Group
4250 Norex Dr.
Chaska,  MN  55318
Correspondent Contact T.L. MILLS
Regulation Number888.1500
Classification Product Code
KQX  
Date Received08/10/1994
Decision Date 11/28/1994
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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