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FDA 510(k)

VERADIUS, MODEL 718-130

K-Number: K090590 · 2009-03-16

ApplicantPhilips Medical Systems North America Co.
Decision Date2009-03-16
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VERADIUS, MODEL 718-130 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 2009-03-16 under 510(k) number K090590. 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 VERADIUS, MODEL 718-130?

VERADIUS, MODEL 718-130 is a medical device that received FDA 510(k) clearance on 2009-03-16. The listed applicant is Philips Medical Systems North America Co.. The 510(k) number is K090590.

When did VERADIUS, MODEL 718-130 receive FDA 510(k) clearance?

VERADIUS, MODEL 718-130 received FDA 510(k) clearance on 2009-03-16, under 510(k) number K090590.

Who is the listed applicant for VERADIUS, MODEL 718-130?

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 VERADIUS, MODEL 718-130?

The FDA product code for VERADIUS, MODEL 718-130 is 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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