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510(k) K171666

MPR2 logO DATALOGGER by Raumedic AG — Product Code GWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2017
Date Received
June 5, 2017
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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  • K182073 — BcSs-PICNI-2000 Sensor (October 17, 2019)
  • K183406 — CereLink ICP Monitor, CereLink ICP Extension Cable (January 11, 2019)