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FDA 510(k)

Rooti Rx ECG Event Recorder, Rooti Link APP Software

K-Number: K163694 · 2017-11-07

ApplicantRooti Labs , Ltd.
Decision Date2017-11-07
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Rooti Labs , Ltd.. The 510(k) number is K163694.

When was Rooti Rx ECG Event Recorder, Rooti Link APP Software approved by the FDA?

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

What company makes Rooti Rx ECG Event Recorder, Rooti Link APP Software?

Rooti Rx ECG Event Recorder, Rooti Link APP Software is manufactured by Rooti Labs , Ltd..

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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Official Source

View on FDA Database →

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