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FDA 510(k)

ALLURA XPER FD10

K-Number: K041949 · 2004-07-30

ApplicantPhilips Medical Systems North America Co.
Decision Date2004-07-30
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ALLURA XPER FD10 is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems North America Co.. It received FDA 510(k) clearance on 2004-07-30 under 510(k) number K041949. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALLURA XPER FD10?

ALLURA XPER FD10 is a medical device that received FDA 510(k) clearance on 2004-07-30. The listed applicant is Philips Medical Systems North America Co.. The 510(k) number is K041949.

When did ALLURA XPER FD10 receive FDA 510(k) clearance?

ALLURA XPER FD10 received FDA 510(k) clearance on 2004-07-30, under 510(k) number K041949.

Who is the listed applicant for ALLURA XPER FD10?

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

What is the FDA product code for ALLURA XPER FD10?

The FDA product code for ALLURA XPER FD10 is IZI.

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Related Devices (Code: IZI)

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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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