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FDA 510(k)

NEXAN SYSTEM, MODEL NX-301

K-Number: K010424 · 2001-09-04

ApplicantNexan, Ltd.
Decision Date2001-09-04
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NEXAN SYSTEM, MODEL NX-301 is the device name listed in this FDA 510(k) record. The listed applicant is Nexan, Ltd.. It received FDA 510(k) clearance on 2001-09-04 under 510(k) number K010424. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEXAN SYSTEM, MODEL NX-301?

NEXAN SYSTEM, MODEL NX-301 is a medical device that received FDA 510(k) clearance on 2001-09-04. The listed applicant is Nexan, Ltd.. The 510(k) number is K010424.

When did NEXAN SYSTEM, MODEL NX-301 receive FDA 510(k) clearance?

NEXAN SYSTEM, MODEL NX-301 received FDA 510(k) clearance on 2001-09-04, under 510(k) number K010424.

Who is the listed applicant for NEXAN SYSTEM, MODEL NX-301?

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

What is the FDA product code for NEXAN SYSTEM, MODEL NX-301?

The FDA product code for NEXAN SYSTEM, MODEL NX-301 is MWI.

Related Clinical Trials

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.

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Other records listing Nexan, Ltd. 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.

K003520NEXAN SYSTEM, MODEL NX-300

Related Devices (Code: MWI)

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.

K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc.K253417Masimo Root Monitoring SystemMasimo CorporationK253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark CorporationK253436c-med0 alphaCosinuss GmbHK250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel MedicalK241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV

Official Source

View on FDA Database →

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

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