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FDA 510(k)

MODIFICATION TO M2376A DEVICELINK SYSTEM

K-Number: K020494 · 2002-02-21

ApplicantPhilips Medical Systems, Inc.
Decision Date2002-02-21
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, Inc.. It received FDA 510(k) clearance on 2002-02-21 under 510(k) number K020494. 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 2002-02-21. The listed applicant is Philips Medical Systems, Inc.. The 510(k) number is K020494.

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

MODIFICATION TO M2376A DEVICELINK SYSTEM received FDA 510(k) clearance on 2002-02-21, under 510(k) number K020494.

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

The FDA 510(k) record lists Philips Medical Systems, Inc. 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, Inc. 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.

K093355PCR ELEVA 1.2K090808PINNACLE3 SMARTARCK071391PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521K063783PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132AK041741M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIENK040955M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.01 AND INTELLIVUE CLINICAL NETWORK ON VLAN

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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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