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FDA 510(k)

Alio Medical Remote Monitoring System

K-Number: K211365 · 2022-03-24

ApplicantGraftworx, Inc. Dba Alio
Decision Date2022-03-24
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Alio Medical Remote Monitoring System is a medical device manufactured by Graftworx, Inc. Dba Alio. It received FDA 510(k) clearance on 2022-03-24 under approval number K211365. 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 Alio Medical Remote Monitoring System?

Alio Medical Remote Monitoring System is a medical device that received FDA 510(k) clearance on 2022-03-24. It is manufactured by Graftworx, Inc. Dba Alio. The 510(k) number is K211365.

When was Alio Medical Remote Monitoring System approved by the FDA?

Alio Medical Remote Monitoring System received FDA 510(k) clearance on 2022-03-24, under approval number K211365.

What company makes Alio Medical Remote Monitoring System?

Alio Medical Remote Monitoring System is manufactured by Graftworx, Inc. Dba Alio.

What is the FDA product code for Alio Medical Remote Monitoring System?

The FDA product code for Alio Medical Remote Monitoring System is DRG.

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Related PubMed Literature

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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