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FDA 510(k)

MPR2 logO DATALOGGER

K-Number: K171666 · 2017-07-06

ApplicantRaumedic AG
Decision Date2017-07-06
Product CodeGWM
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MPR2 logO DATALOGGER is the device name listed in this FDA 510(k) record. The listed applicant is Raumedic AG. It received FDA 510(k) clearance on 2017-07-06 under 510(k) 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. The listed applicant is Raumedic AG. The 510(k) number is K171666.

When did MPR2 logO DATALOGGER receive FDA 510(k) clearance?

MPR2 logO DATALOGGER received FDA 510(k) clearance on 2017-07-06, under 510(k) number K171666.

Who is the listed applicant for MPR2 logO DATALOGGER?

The FDA 510(k) record lists Raumedic AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MPR2 logO DATALOGGER?

The FDA product code for MPR2 logO DATALOGGER is GWM.

Other records listing Raumedic AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250285NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOL

Related Devices (Code: GWM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252241Pressio 3 Multi-parameter Neuromonitoring SystemSophysaK250285NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOLRaumedic AGK240821B4C System - Addition of new sensor model (BcSs-PICNIW-2000)Braincare Desenvolvimento E Inovação Tecnológica S.A.K232890CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)Integra Lifesciences Production CorporationK201989B4C SystemBraincare Desenvolvimento E Inovacao Tecnologica S.A.K210993CereLink ICP MonitorIntegra Lifesciences Production Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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