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510(k) K042208

ISIS MER SYSTEM/ELEKTA MER SYSTEM by Inomed Medizintechnik GmbH — Product Code GZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2005
Date Received
August 16, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Depth
Device Class
Class II
Regulation Number
882.1330
Review Panel
NE
Submission Type

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