FDA 510(k)

CereLink ICP Monitor

Numéro K : K210993 · 2021-04-30

DemandeurIntegra Lifesciences Production Corporation

Date de décision2021-04-30

Code produitGWM

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

CereLink ICP Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Integra Lifesciences Production Corporation. It received FDA 510(k) clearance on 2021-04-30 under 510(k) number K210993. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the CereLink ICP Monitor?

CereLink ICP Monitor is a medical device that received FDA 510(k) clearance on 2021-04-30. The listed applicant is Integra Lifesciences Production Corporation. The 510(k) number is K210993.

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

CereLink ICP Monitor received FDA 510(k) clearance on 2021-04-30, under 510(k) number K210993.

Who is the listed applicant for CereLink ICP Monitor?

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

What is the FDA product code for CereLink ICP Monitor?

The FDA product code for CereLink ICP Monitor is GWM.

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Dispositifs connexes (Code : 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.K201118Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser LevelMedtronic, Inc.

Source officielle

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