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FDA 510(k)

M2376A DEVICELINK SYSTEM

K-Number: K041942 · 2004-07-23

ApplicantPhillips Medical Systems
Decision Date2004-07-23
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

M2376A DEVICELINK SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Phillips Medical Systems. It received FDA 510(k) clearance on 2004-07-23 under 510(k) number K041942. 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 M2376A DEVICELINK SYSTEM?

M2376A DEVICELINK SYSTEM is a medical device that received FDA 510(k) clearance on 2004-07-23. The listed applicant is Phillips Medical Systems. The 510(k) number is K041942.

When did M2376A DEVICELINK SYSTEM receive FDA 510(k) clearance?

M2376A DEVICELINK SYSTEM received FDA 510(k) clearance on 2004-07-23, under 510(k) number K041942.

Who is the listed applicant for M2376A DEVICELINK SYSTEM?

The FDA 510(k) record lists Phillips Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for M2376A DEVICELINK SYSTEM?

The FDA product code for M2376A DEVICELINK SYSTEM 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 Phillips Medical Systems 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.

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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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