FDA 510(k)

TraumaCad Mobile Release 2.0

Número K: K160001 · 2016-02-12

Data da decisão2016-02-12

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

TraumaCad Mobile Release 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Voyant Health, Ltd.. It received FDA 510(k) clearance on 2016-02-12 under 510(k) number K160001. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is Voyant Health, Ltd.. The 510(k) number is K160001.

When did TraumaCad Mobile Release 2.0 receive FDA 510(k) clearance?

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

Who is the listed applicant for TraumaCad Mobile Release 2.0?

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

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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