FDA 510(k)

WebPAX

Número K: K152949 · 2016-08-17

RequerenteHeart Imaging Technologies, LLC

Data da decisão2016-08-17

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

WebPAX is the device name listed in this FDA 510(k) record. The listed applicant is Heart Imaging Technologies, LLC. It received FDA 510(k) clearance on 2016-08-17 under 510(k) number K152949. 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 WebPAX?

WebPAX is a medical device that received FDA 510(k) clearance on 2016-08-17. The listed applicant is Heart Imaging Technologies, LLC. The 510(k) number is K152949.

When did WebPAX receive FDA 510(k) clearance?

WebPAX received FDA 510(k) clearance on 2016-08-17, under 510(k) number K152949.

Who is the listed applicant for WebPAX?

The FDA 510(k) record lists Heart Imaging Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WebPAX?

The FDA product code for WebPAX is LLZ.

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