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FDA 510(k)

ALLURA XPER OR TABLE SERIES

K-Number: K102005 · 2010-08-09

ApplicantPhilips Medical Systems North America, Inc.
Decision Date2010-08-09
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ALLURA XPER OR TABLE SERIES 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 2010-08-09 under 510(k) number K102005. 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 ALLURA XPER OR TABLE SERIES?

ALLURA XPER OR TABLE SERIES is a medical device that received FDA 510(k) clearance on 2010-08-09. The listed applicant is Philips Medical Systems North America, Inc.. The 510(k) number is K102005.

When did ALLURA XPER OR TABLE SERIES receive FDA 510(k) clearance?

ALLURA XPER OR TABLE SERIES received FDA 510(k) clearance on 2010-08-09, under 510(k) number K102005.

Who is the listed applicant for ALLURA XPER OR TABLE SERIES?

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 ALLURA XPER OR TABLE SERIES?

The FDA product code for ALLURA XPER OR TABLE SERIES is OWB.

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Other records listing Philips Medical Systems North America, Inc. as applicant

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Related Devices (Code: OWB)

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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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