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FDA 510(k)

Cadwell Guardian

K-Number: K230415 · 2023-08-17

ApplicantCadwell Industries, Inc.
Decision Date2023-08-17
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Cadwell Guardian 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 2023-08-17 under 510(k) number K230415. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cadwell Guardian?

Cadwell Guardian is a medical device that received FDA 510(k) clearance on 2023-08-17. The listed applicant is Cadwell Industries, Inc.. The 510(k) number is K230415.

When did Cadwell Guardian receive FDA 510(k) clearance?

Cadwell Guardian received FDA 510(k) clearance on 2023-08-17, under 510(k) number K230415.

Who is the listed applicant for Cadwell Guardian?

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 Guardian?

The FDA product code for Cadwell Guardian is GWF.

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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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