Optum TeleHealth Application
K-Number: K171406 · 2017-08-18
ApplicantUnited Health Group, Inc.
Decision Date2017-08-18
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Optum TeleHealth Application is a medical device manufactured by United Health Group, Inc.. It received FDA 510(k) clearance on 2017-08-18 under approval number K171406. 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 Optum TeleHealth Application?
Optum TeleHealth Application is a medical device that received FDA 510(k) clearance on 2017-08-18. It is manufactured by United Health Group, Inc.. The 510(k) number is K171406.
When was Optum TeleHealth Application approved by the FDA?
Optum TeleHealth Application received FDA 510(k) clearance on 2017-08-18, under approval number K171406.
What company makes Optum TeleHealth Application?
Optum TeleHealth Application is manufactured by United Health Group, Inc..
What is the FDA product code for Optum TeleHealth Application?
The FDA product code for Optum TeleHealth Application is DRG.
Related Devices (Code: DRG)
K161916TelePatch Cardiac MonitorMedicomp, Inc.
K153719LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStreamHoneywell Hommed, LLC
K163694Rooti Rx ECG Event Recorder, Rooti Link APP SoftwareRooti Labs , Ltd.
K163453VitalPatch® VitalConnect PlatformVitalconnect, Inc.
K171029eCareCoordinatorVisicu, Inc.
K171188Ossler Exam ScopeLr Med, 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.