FDA 510(k)

TraumaCad Mobile Release 2.0

K-Number: K160001 · 2016-02-12

Decision Date2016-02-12

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

TraumaCad Mobile Release 2.0 is a medical device manufactured by Voyant Health, Ltd.. It received FDA 510(k) clearance on 2016-02-12 under approval number K160001. 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 TraumaCad Mobile Release 2.0?

TraumaCad Mobile Release 2.0 is a medical device that received FDA 510(k) clearance on 2016-02-12. It is manufactured by Voyant Health, Ltd.. The 510(k) number is K160001.

When was TraumaCad Mobile Release 2.0 approved by the FDA?

TraumaCad Mobile Release 2.0 received FDA 510(k) clearance on 2016-02-12, under approval number K160001.

What company makes TraumaCad Mobile Release 2.0?

TraumaCad Mobile Release 2.0 is manufactured by Voyant Health, Ltd..

What is the FDA product code for TraumaCad Mobile Release 2.0?

The FDA product code for TraumaCad Mobile Release 2.0 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.