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FDA 510(k)

XPERCT REL. 3

K-Number: K130893 · 2013-09-06

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2013-09-06
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XPERCT REL. 3 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 2013-09-06 under 510(k) number K130893. 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 XPERCT REL. 3?

XPERCT REL. 3 is a medical device that received FDA 510(k) clearance on 2013-09-06. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K130893.

When did XPERCT REL. 3 receive FDA 510(k) clearance?

XPERCT REL. 3 received FDA 510(k) clearance on 2013-09-06, under 510(k) number K130893.

Who is the listed applicant for XPERCT REL. 3?

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 XPERCT REL. 3?

The FDA product code for XPERCT REL. 3 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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