FDA 510(k)

CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)

Numéro K : K232890 · 2024-02-04

DemandeurIntegra Lifesciences Production Corporation

Date de décision2024-02-04

Code produitGWM

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) 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 2024-02-04 under 510(k) number K232890. 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 (826820), CereLink ICP Extension Cable (826845)?

CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) is a medical device that received FDA 510(k) clearance on 2024-02-04. The listed applicant is Integra Lifesciences Production Corporation. The 510(k) number is K232890.

When did CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) receive FDA 510(k) clearance?

CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) received FDA 510(k) clearance on 2024-02-04, under 510(k) number K232890.

Who is the listed applicant for CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)?

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 (826820), CereLink ICP Extension Cable (826845)?

The FDA product code for CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) is GWM.

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Dispositifs connexes (Code : GWM)

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Source officielle

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