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FDA 510(k)

PHILIPS INTURIS CARDIO IMAGE VIEWING PACKAGE

K-Number: K983821 · 1998-12-11

ApplicantPhilips Medical Systems North America, Inc.
Decision Date1998-12-11
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PHILIPS INTURIS CARDIO IMAGE VIEWING PACKAGE is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems North America, Inc.. It received FDA 510(k) clearance on 1998-12-11 under 510(k) number K983821. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHILIPS INTURIS CARDIO IMAGE VIEWING PACKAGE?

PHILIPS INTURIS CARDIO IMAGE VIEWING PACKAGE is a medical device that received FDA 510(k) clearance on 1998-12-11. The listed applicant is Philips Medical Systems North America, Inc.. The 510(k) number is K983821.

When did PHILIPS INTURIS CARDIO IMAGE VIEWING PACKAGE receive FDA 510(k) clearance?

PHILIPS INTURIS CARDIO IMAGE VIEWING PACKAGE received FDA 510(k) clearance on 1998-12-11, under 510(k) number K983821.

Who is the listed applicant for PHILIPS INTURIS CARDIO IMAGE VIEWING PACKAGE?

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

What is the FDA product code for PHILIPS INTURIS CARDIO IMAGE VIEWING PACKAGE?

The FDA product code for PHILIPS INTURIS CARDIO IMAGE VIEWING PACKAGE is LLZ.

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Other records listing Philips Medical Systems North America, 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.

K102005ALLURA XPER OR TABLE SERIESK062233HEARTSTART MRX MONITOR/DEFIBRILLATORK062283THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MONITORSK061052THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90K050151MULTIDIAGNOST ELEVAK042867PHILIPS ORTHOPAEDIC APPLICATIONS

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Related Devices (Code: LLZ)

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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