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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electromyograph, Diagnostic
510(k) Number K912071
Device Name SPACE(TM) 7500
Applicant
F.M. Wiest USA, Inc.
690 Kinderkamack Rd., 1st Floor
P.O. Box 637
Oradell,  NJ  07649
Applicant Contact GEORGE R BATCHELOR
Correspondent
F.M. Wiest USA, Inc.
690 Kinderkamack Rd., 1st Floor
P.O. Box 637
Oradell,  NJ  07649
Correspondent Contact GEORGE R BATCHELOR
Regulation Number890.1375
Classification Product Code
IKN  
Date Received05/10/1991
Decision Date 07/09/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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