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

FDA 510(k)

Comarch e-Care Platform

K-Number: K181248 · 2018-10-22

ApplicantComarch Healthcare SA
Decision Date2018-10-22
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Comarch e-Care Platform is a medical device manufactured by Comarch Healthcare SA. It received FDA 510(k) clearance on 2018-10-22 under approval number K181248. 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 Comarch e-Care Platform?

Comarch e-Care Platform is a medical device that received FDA 510(k) clearance on 2018-10-22. It is manufactured by Comarch Healthcare SA. The 510(k) number is K181248.

When was Comarch e-Care Platform approved by the FDA?

Comarch e-Care Platform received FDA 510(k) clearance on 2018-10-22, under approval number K181248.

What company makes Comarch e-Care Platform?

Comarch e-Care Platform is manufactured by Comarch Healthcare SA.

What is the FDA product code for Comarch e-Care Platform?

The FDA product code for Comarch e-Care Platform 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. K171406Optum TeleHealth ApplicationUnited Health Group, Inc. K171029eCareCoordinatorVisicu, 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.

↑