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FDA 510(k)

Cadwell Zenith System

K-Number: K181466 · 2018-09-01

ApplicantCadwell Industries, Inc.
Decision Date2018-09-01
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Cadwell Zenith System is the device name listed in this FDA 510(k) record. The listed applicant is Cadwell Industries, Inc.. It received FDA 510(k) clearance on 2018-09-01 under 510(k) number K181466. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cadwell Zenith System?

Cadwell Zenith System is a medical device that received FDA 510(k) clearance on 2018-09-01. The listed applicant is Cadwell Industries, Inc.. The 510(k) number is K181466.

When did Cadwell Zenith System receive FDA 510(k) clearance?

Cadwell Zenith System received FDA 510(k) clearance on 2018-09-01, under 510(k) number K181466.

Who is the listed applicant for Cadwell Zenith System?

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

What is the FDA product code for Cadwell Zenith System?

The FDA product code for Cadwell Zenith System is GWQ.

Other records listing Cadwell Industries, Inc. as applicant

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Related Devices (Code: GWQ)

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.

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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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