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FDA 510(k)

Athena GTX Device Management Suite (ADMS) Software

K-Number: K173203 · 2018-03-14

ApplicantAthena Gtx
Decision Date2018-03-14
Product CodeMSX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Athena GTX Device Management Suite (ADMS) Software is the device name listed in this FDA 510(k) record. The listed applicant is Athena Gtx. It received FDA 510(k) clearance on 2018-03-14 under 510(k) number K173203. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Athena GTX Device Management Suite (ADMS) Software?

Athena GTX Device Management Suite (ADMS) Software is a medical device that received FDA 510(k) clearance on 2018-03-14. The listed applicant is Athena Gtx. The 510(k) number is K173203.

When did Athena GTX Device Management Suite (ADMS) Software receive FDA 510(k) clearance?

Athena GTX Device Management Suite (ADMS) Software received FDA 510(k) clearance on 2018-03-14, under 510(k) number K173203.

Who is the listed applicant for Athena GTX Device Management Suite (ADMS) Software?

The FDA 510(k) record lists Athena Gtx as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Athena GTX Device Management Suite (ADMS) Software?

The FDA product code for Athena GTX Device Management Suite (ADMS) Software is MSX.

Other records listing Athena Gtx as applicant

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.

K233354WVSM Pro (Series) (500-0030-XX)K191989WVSM (Wireless Vital Signs Monitor) RWC + miniCapK160582WiCapK153459TACVAC

Related Devices (Code: MSX)

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.

K260211Dashboard (P007000)Hill-Rom, Inc.K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbHK243270TigerConnect Alarm ManagementTigerconnectK242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.K242750Central StationNihon Kohden Digital Health Solutions, LLC

Official Source

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

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