Decision Date2017-07-06
Product CodeGWM
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
MPR2 logO DATALOGGER is a medical device manufactured by Raumedic AG. It received FDA 510(k) clearance on 2017-07-06 under approval number K171666. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MPR2 logO DATALOGGER?
MPR2 logO DATALOGGER is a medical device that received FDA 510(k) clearance on 2017-07-06. It is manufactured by Raumedic AG. The 510(k) number is K171666.
When was MPR2 logO DATALOGGER approved by the FDA?
MPR2 logO DATALOGGER received FDA 510(k) clearance on 2017-07-06, under approval number K171666.
What company makes MPR2 logO DATALOGGER?
MPR2 logO DATALOGGER is manufactured by Raumedic AG.
What is the FDA product code for MPR2 logO DATALOGGER?
The FDA product code for MPR2 logO DATALOGGER is GWM.
Other Devices by Raumedic AG
Related Devices (Code: GWM)
K161010HICP200 Patient/Monitor Interconnect CableInnerspace Neuro Solutions, Inc.
K153347Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter KitCodman & Shurtleff, Inc.
K152670DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface CablesMedos International SARL
K173192CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter KitCodman & Shurtleff, Inc.
K162108Pressio 2 ICP Monitoring SystemSophysa SA
K172209AURA ICP MONITORING SYSTEMBranchpoint Technologies, Inc.
Official Source
View on FDA Database →
Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.