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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
Recalls CDRH Recalls
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