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FDA 510(k)

XPS 3000 SYSTEM

K-Number: K002224 · 2000-12-04

ApplicantMedtronic Xomed
Decision Date2000-12-04
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

XPS 3000 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Xomed. It received FDA 510(k) clearance on 2000-12-04 under 510(k) number K002224. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XPS 3000 SYSTEM?

XPS 3000 SYSTEM is a medical device that received FDA 510(k) clearance on 2000-12-04. The listed applicant is Medtronic Xomed. The 510(k) number is K002224.

When did XPS 3000 SYSTEM receive FDA 510(k) clearance?

XPS 3000 SYSTEM received FDA 510(k) clearance on 2000-12-04, under 510(k) number K002224.

Who is the listed applicant for XPS 3000 SYSTEM?

The FDA 510(k) record lists Medtronic Xomed as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XPS 3000 SYSTEM?

The FDA product code for XPS 3000 SYSTEM is ERL.

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Related Devices (Code: ERL)

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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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