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FDA 510(k)

MODIFICATION TO M2376A DEVICELINK SYSTEM

K-Number: K021347 · 2002-05-07

ApplicantPhilips Medical Systems
Decision Date2002-05-07
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO M2376A DEVICELINK SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems. It received FDA 510(k) clearance on 2002-05-07 under 510(k) number K021347. 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 MODIFICATION TO M2376A DEVICELINK SYSTEM?

MODIFICATION TO M2376A DEVICELINK SYSTEM is a medical device that received FDA 510(k) clearance on 2002-05-07. The listed applicant is Philips Medical Systems. The 510(k) number is K021347.

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

MODIFICATION TO M2376A DEVICELINK SYSTEM received FDA 510(k) clearance on 2002-05-07, under 510(k) number K021347.

Who is the listed applicant for MODIFICATION TO M2376A DEVICELINK SYSTEM?

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

What is the FDA product code for MODIFICATION TO M2376A DEVICELINK SYSTEM?

The FDA product code for MODIFICATION TO M2376A DEVICELINK SYSTEM is MWI.

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Other records listing Philips Medical Systems as applicant

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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.

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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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