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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Depth
510(k) Number K042208
Device Name ISIS MER SYSTEM/ELEKTA MER SYSTEM
Applicant
INOMED MEDIZINTECHNIK GMBH
KUNGSTENSGATAN 18, PO BX 7593
STOCKHOLM,  DE SE-103 93
Applicant Contact ANDERS SKOGLUND
Correspondent
INOMED MEDIZINTECHNIK GMBH
KUNGSTENSGATAN 18, PO BX 7593
STOCKHOLM,  DE SE-103 93
Correspondent Contact ANDERS SKOGLUND
Regulation Number882.1330
Classification Product Code
GZL  
Date Received08/16/2004
Decision Date 03/18/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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