FDA 510(k)

CS Model+

K-Number: K193390 · 2020-04-02

ApplicantTrophy

Decision Date2020-04-02

Product CodePNN

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

CS Model+ is the device name listed in this FDA 510(k) record. The listed applicant is Trophy. It received FDA 510(k) clearance on 2020-04-02 under 510(k) number K193390. The device is classified under product code PNN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CS Model+?

CS Model+ is a medical device that received FDA 510(k) clearance on 2020-04-02. The listed applicant is Trophy. The 510(k) number is K193390.

When did CS Model+ receive FDA 510(k) clearance?

CS Model+ received FDA 510(k) clearance on 2020-04-02, under 510(k) number K193390.

Who is the listed applicant for CS Model+?

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

What is the FDA product code for CS Model+?

The FDA product code for CS Model+ is PNN.

Other records listing Trophy 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.

K200183CS 9600 K181136CS 9600 K173622CS Imaging

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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.