FDA 510(k)

emField

K-Number: K203488 · 2021-02-19

Decision Date2021-02-19

Product CodeIPF

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

emField is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Medizinsysteme GmbH. It received FDA 510(k) clearance on 2021-02-19 under 510(k) number K203488. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the emField?

emField is a medical device that received FDA 510(k) clearance on 2021-02-19. The listed applicant is Zimmer Medizinsysteme GmbH. The 510(k) number is K203488.

When did emField receive FDA 510(k) clearance?

emField received FDA 510(k) clearance on 2021-02-19, under 510(k) number K203488.

Who is the listed applicant for emField?

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

What is the FDA product code for emField?

The FDA product code for emField is IPF.

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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.