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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 a medical device manufactured by Athena Gtx. It received FDA 510(k) clearance on 2020-01-29 under approval 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. It is manufactured by Athena Gtx. The 510(k) number is K191989.

When was WVSM (Wireless Vital Signs Monitor) RWC + miniCap approved by the FDA?

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

What company makes WVSM (Wireless Vital Signs Monitor) RWC + miniCap?

WVSM (Wireless Vital Signs Monitor) RWC + miniCap is manufactured by Athena Gtx.

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

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Related PubMed Literature

PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 40085833 The Measurement of Vital Signs in Pediatric Patients by Lifelight Software in Comparison to the Standard of Care: Protocol for the VISION-Junior Observational Study. JMIR research protocols (2025)

Other Devices by Athena Gtx

K160582WiCap K153459TACVAC K173203Athena GTX Device Management Suite (ADMS) Software

Related Devices (Code: MWI)

K161909IQvitals ZoneMidmark Corporation K160718Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien K151839AMC Health VitalCaregiving SystemAmc Health K160956LD-Oxi systemLd Technology, LLC K153739MRI Patient Monitor TeslaDUOMipm Mammendorfer Institut Fur Physik Und Medizin K153225Masimo Root Monitoring System and AccessoriesMasimo Corporation

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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