FDA 510(k)

MPR2 logO DATALOGGER

N.º K: K171666 · 2017-07-06

Fecha de decisión2017-07-06

Código de productoGWM

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

Ensayos clínicos relacionados

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Otros registros que enlistan a Raumedic AG como solicitante

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

Dispositivos relacionados (Código: GWM)

K252241Pressio 3 Multi-parameter Neuromonitoring SystemSophysa 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); BOLRaumedic AG K240821B4C 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 Corporation K201989B4C SystemBraincare Desenvolvimento E Inovacao Tecnologica S.A.K210993CereLink ICP MonitorIntegra Lifesciences Production Corporation

Fuente oficial

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