FDA 510(k)

XP202

K-Number: K161922 · 2016-09-01

Decision Date2016-09-01

Product CodeEIH

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

XP202 is the device name listed in this FDA 510(k) record. The listed applicant is 3M Deutschland GmbH. It received FDA 510(k) clearance on 2016-09-01 under 510(k) number K161922. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XP202?

XP202 is a medical device that received FDA 510(k) clearance on 2016-09-01. The listed applicant is 3M Deutschland GmbH. The 510(k) number is K161922.

When did XP202 receive FDA 510(k) clearance?

XP202 received FDA 510(k) clearance on 2016-09-01, under 510(k) number K161922.

Who is the listed applicant for XP202?

The FDA 510(k) record lists 3M Deutschland GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XP202?

The FDA product code for XP202 is EIH.

Other records listing 3M Deutschland GmbH as applicant

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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.