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FDA 510(k)

CT CoPilot

K-Number: K161322 · 2016-12-07

ApplicantZepmed, LLC
Decision Date2016-12-07
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CT CoPilot is a medical device manufactured by Zepmed, LLC. It received FDA 510(k) clearance on 2016-12-07 under approval number K161322. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CT CoPilot?

CT CoPilot is a medical device that received FDA 510(k) clearance on 2016-12-07. It is manufactured by Zepmed, LLC. The 510(k) number is K161322.

When was CT CoPilot approved by the FDA?

CT CoPilot received FDA 510(k) clearance on 2016-12-07, under approval number K161322.

What company makes CT CoPilot?

CT CoPilot is manufactured by Zepmed, LLC.

What is the FDA product code for CT CoPilot?

The FDA product code for CT CoPilot is LLZ.

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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.

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