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FDA 510(k)

PHILIPS INTEGRIS ALLURA

K-Number: K002016 · 2000-09-06

ApplicantPhilips Medical Systems North America, Inc.
Decision Date2000-09-06
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PHILIPS INTEGRIS ALLURA 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 2000-09-06 under 510(k) number K002016. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHILIPS INTEGRIS ALLURA?

PHILIPS INTEGRIS ALLURA is a medical device that received FDA 510(k) clearance on 2000-09-06. The listed applicant is Philips Medical Systems North America, Inc.. The 510(k) number is K002016.

When did PHILIPS INTEGRIS ALLURA receive FDA 510(k) clearance?

PHILIPS INTEGRIS ALLURA received FDA 510(k) clearance on 2000-09-06, under 510(k) number K002016.

Who is the listed applicant for PHILIPS INTEGRIS ALLURA?

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 INTEGRIS ALLURA?

The FDA product code for PHILIPS INTEGRIS ALLURA is OWB.

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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: OWB)

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.

K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.K261413EXTRON 3;EXTRON 6DRTECH CorporationK254205Zenition 30Philips Medical Systems Nederland B.V.K260607Shield System (Siemens 30x40)Radiaction , Ltd.K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.K252735C-beamPulmera, Inc.

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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