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FDA 510(k)

XPERGUIDE

K-Number: K131263 · 2013-07-24

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2013-07-24
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XPERGUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2013-07-24 under 510(k) number K131263. 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 XPERGUIDE?

XPERGUIDE is a medical device that received FDA 510(k) clearance on 2013-07-24. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K131263.

When did XPERGUIDE receive FDA 510(k) clearance?

XPERGUIDE received FDA 510(k) clearance on 2013-07-24, under 510(k) number K131263.

Who is the listed applicant for XPERGUIDE?

The FDA 510(k) record lists Philips Medical Systems Nederland B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XPERGUIDE?

The FDA product code for XPERGUIDE is OWB.

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Other records listing Philips Medical Systems Nederland B.V. as applicant

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Related Devices (Code: OWB)

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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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