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510(k) K171666

MPR2 logO DATALOGGER by Raumedic AG — Product Code GWM

K171666 is an FDA 510(k) premarket notification submitted by Raumedic AG for the device "MPR2 logO DATALOGGER". The FDA issued a decision of Substantially Equivalent on July 6, 2017. The device falls under product code GWM (Device, Monitoring, Intracranial Pressure), a Class II device regulated under 21 CFR 882.1620. Raumedic AG has at least 5 other 510(k) clearances on record.

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

Other clearances by Raumedic AG

  • K250285 — NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); (August 29, 2025)
  • K130529 — RAUMEDIC-PTO-MONITORING-SYSTEM (October 25, 2013)
  • K120252 — RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM (April 11, 2012)
  • K112017 — RAUMEDIC ICP MONITORING SYSTEM (October 11, 2011)
  • K103206 — RAUMEDIC- ICP-MONITORING SYSTEM (March 4, 2011)

Other clearances for product code GWM

  • K252241 — Pressio 3 Multi-parameter Neuromonitoring System (April 10, 2026)
  • K250285 — NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); (August 29, 2025)
  • K240821 — B4C System - Addition of new sensor model (BcSs-PICNIW-2000) (July 18, 2024)
  • K232890 — CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) (February 4, 2024)
  • K201989 — B4C System (October 8, 2021)
  • K210993 — CereLink ICP Monitor (April 30, 2021)
  • K201118 — Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Ex (May 26, 2020)
  • K200630 — Medtronic External Drainage and Monitoring System, Medtronic External Drainage a (April 9, 2020)
  • K200456 — Becker External Drainage and Monitoring System (March 26, 2020)
  • K182073 — BcSs-PICNI-2000 Sensor (October 17, 2019)

FDA data resources