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510(k) K120252

RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM by Raumedic AG — Product Code GWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2012
Date Received
January 27, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Device, Monitoring, Intracranial Pressure
Device Class
Class II
Regulation Number
882.1620
Review Panel
NE
Submission Type

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  • K183406 — CereLink ICP Monitor, CereLink ICP Extension Cable (January 11, 2019)