Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Graftworx, Inc. Dba Alio. It received FDA 510(k) clearance on 2022-03-24 under 510(k) 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. The listed applicant is Graftworx, Inc. Dba Alio. The 510(k) number is K211365.

When did Alio Medical Remote Monitoring System receive FDA 510(k) clearance?

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

Who is the listed applicant for Alio Medical Remote Monitoring System?

The FDA 510(k) record lists Graftworx, Inc. Dba Alio as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: DRG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.K252984Perin Health System (PHD80060-2)Perin Health Devices, LLCK252440EasyTeleMed (2.0.2)Ingeniars S.R.L.K250259TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare CorporationK243837iBSMIorbit Digital Technologies Private LimitedK242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.

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.

↑