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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 K990766
Device Name CERSR ELECTROMYOGRAPHY SYSTEM
Applicant
Paraspinal Diagnostic Corp.
11605 Hitching Post Ln.
Rockville,  MD  20852
Applicant Contact JOEL S FADEN
Correspondent
Paraspinal Diagnostic Corp.
11605 Hitching Post Ln.
Rockville,  MD  20852
Correspondent Contact JOEL S FADEN
Regulation Number890.1375
Classification Product Code
IKN  
Date Received03/08/1999
Decision Date 08/27/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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