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FDA 510(k)

WVSM (Wireless Vital Signs Monitor) RWC + miniCap

K-Number: K191989 · 2020-01-29

ApplicantAthena Gtx
Decision Date2020-01-29
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WVSM (Wireless Vital Signs Monitor) RWC + miniCap is the device name listed in this FDA 510(k) record. The listed applicant is Athena Gtx. It received FDA 510(k) clearance on 2020-01-29 under 510(k) number K191989. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WVSM (Wireless Vital Signs Monitor) RWC + miniCap?

WVSM (Wireless Vital Signs Monitor) RWC + miniCap is a medical device that received FDA 510(k) clearance on 2020-01-29. The listed applicant is Athena Gtx. The 510(k) number is K191989.

When did WVSM (Wireless Vital Signs Monitor) RWC + miniCap receive FDA 510(k) clearance?

WVSM (Wireless Vital Signs Monitor) RWC + miniCap received FDA 510(k) clearance on 2020-01-29, under 510(k) number K191989.

Who is the listed applicant for WVSM (Wireless Vital Signs Monitor) RWC + miniCap?

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 WVSM (Wireless Vital Signs Monitor) RWC + miniCap?

The FDA product code for WVSM (Wireless Vital Signs Monitor) RWC + miniCap is MWI.

Related Clinical Trials

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.

NCT06693817Advanced Wireless Sensors for Neonatal Care in the Delivery RoomRECRUITINGNCT07739823Validation of a Wireless Wearable Vital Signs Monitor in Pediatric PatientNOT_YET_RECRUITINGNCT02907255Vital Sign Monitoring With Continuous Pulse Oximetry and Wireless Clinician Notification After SurgeryCOMPLETEDNCT04011163Vital Signs-Integrated Patient-Assisted Intravenous Opioid Analgesia for Post Surgical PainACTIVE_NOT_RECRUITINGNCT04723654Evaluating Wearable Smart Sensors for Continuous Measurement of Vital Signs in ICU PatientsRECRUITINGNCT06238180Personalised Real-time Interoperable Sepsis Monitoring (PRISM)WITHDRAWN

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)K173203Athena GTX Device Management Suite (ADMS) SoftwareK160582WiCapK153459TACVAC

Related Devices (Code: MWI)

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.

K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc.K253417Masimo Root Monitoring SystemMasimo CorporationK253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark CorporationK253436c-med0 alphaCosinuss GmbHK250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel MedicalK241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV

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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