FDA 510(k)

CereLink ICP Monitor, CereLink ICP Extension Cable

N.º K: K183406 · 2019-01-11

Fecha de decisión2019-01-11

Código de productoGWM

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

CereLink ICP Monitor, CereLink ICP Extension Cable is the device name listed in this FDA 510(k) record. The listed applicant is Integra Lifesciences Corp.. It received FDA 510(k) clearance on 2019-01-11 under 510(k) number K183406. 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 CereLink ICP Monitor, CereLink ICP Extension Cable?

CereLink ICP Monitor, CereLink ICP Extension Cable is a medical device that received FDA 510(k) clearance on 2019-01-11. The listed applicant is Integra Lifesciences Corp.. The 510(k) number is K183406.

When did CereLink ICP Monitor, CereLink ICP Extension Cable receive FDA 510(k) clearance?

CereLink ICP Monitor, CereLink ICP Extension Cable received FDA 510(k) clearance on 2019-01-11, under 510(k) number K183406.

Who is the listed applicant for CereLink ICP Monitor, CereLink ICP Extension Cable?

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

What is the FDA product code for CereLink ICP Monitor, CereLink ICP Extension Cable?

The FDA product code for CereLink ICP Monitor, CereLink ICP Extension Cable is GWM.

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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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