FDA 510(k)

Rooti Rx ECG Event Recorder, Rooti Link APP Software

Número K: K163694 · 2017-11-07

Data da decisão2017-11-07

Código do produtoDRG

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Rooti Rx ECG Event Recorder, Rooti Link APP Software is the device name listed in this FDA 510(k) record. The listed applicant is Rooti Labs , Ltd.. It received FDA 510(k) clearance on 2017-11-07 under 510(k) number K163694. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Rooti Rx ECG Event Recorder, Rooti Link APP Software?

Rooti Rx ECG Event Recorder, Rooti Link APP Software is a medical device that received FDA 510(k) clearance on 2017-11-07. The listed applicant is Rooti Labs , Ltd.. The 510(k) number is K163694.

When did Rooti Rx ECG Event Recorder, Rooti Link APP Software receive FDA 510(k) clearance?

Rooti Rx ECG Event Recorder, Rooti Link APP Software received FDA 510(k) clearance on 2017-11-07, under 510(k) number K163694.

Who is the listed applicant for Rooti Rx ECG Event Recorder, Rooti Link APP Software?

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

What is the FDA product code for Rooti Rx ECG Event Recorder, Rooti Link APP Software?

The FDA product code for Rooti Rx ECG Event Recorder, Rooti Link APP Software is DRG.

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