FDA 510(k)

IPC POWEREASE SYSTEM

K-Number: K111520 · 2011-10-26

Decision Date2011-10-26

Product CodeHBE

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

IPC POWEREASE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Xomed, Inc.. It received FDA 510(k) clearance on 2011-10-26 under 510(k) number K111520. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IPC POWEREASE SYSTEM?

IPC POWEREASE SYSTEM is a medical device that received FDA 510(k) clearance on 2011-10-26. The listed applicant is Medtronic Xomed, Inc.. The 510(k) number is K111520.

When did IPC POWEREASE SYSTEM receive FDA 510(k) clearance?

IPC POWEREASE SYSTEM received FDA 510(k) clearance on 2011-10-26, under 510(k) number K111520.

Who is the listed applicant for IPC POWEREASE SYSTEM?

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

What is the FDA product code for IPC POWEREASE SYSTEM?

The FDA product code for IPC POWEREASE SYSTEM is HBE.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.