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510(k) K130529

RAUMEDIC-PTO-MONITORING-SYSTEM by Raumedic AG — Product Code GWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2013
Date Received
March 1, 2013
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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  • K210993 — CereLink ICP Monitor (April 30, 2021)
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  • K200456 — Becker External Drainage and Monitoring System (March 26, 2020)
  • K182073 — BcSs-PICNI-2000 Sensor (October 17, 2019)
  • K183406 — CereLink ICP Monitor, CereLink ICP Extension Cable (January 11, 2019)