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FDA 510(k)

emFieldPro

K-Number: K182963 · 2019-06-21

Decision Date2019-06-21
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

emFieldPro 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 2019-06-21 under 510(k) number K182963. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the emFieldPro?

emFieldPro is a medical device that received FDA 510(k) clearance on 2019-06-21. The listed applicant is Zimmer Medizinsysteme GmbH. The 510(k) number is K182963.

When did emFieldPro receive FDA 510(k) clearance?

emFieldPro received FDA 510(k) clearance on 2019-06-21, under 510(k) number K182963.

Who is the listed applicant for emFieldPro?

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 emFieldPro?

The FDA product code for emFieldPro is NGX.

Other records listing Zimmer Medizinsysteme GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 13 devices →

Related Devices (Code: NGX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.