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FDA 510(k)

Vios Monitoring System™ Model 2050

K-Number: K172586 · 2018-06-22

ApplicantVios Medical, Inc.
Decision Date2018-06-22
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Vios Monitoring System™ Model 2050 is the device name listed in this FDA 510(k) record. The listed applicant is Vios Medical, Inc.. It received FDA 510(k) clearance on 2018-06-22 under 510(k) number K172586. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vios Monitoring System™ Model 2050?

Vios Monitoring System™ Model 2050 is a medical device that received FDA 510(k) clearance on 2018-06-22. The listed applicant is Vios Medical, Inc.. The 510(k) number is K172586.

When did Vios Monitoring System™ Model 2050 receive FDA 510(k) clearance?

Vios Monitoring System™ Model 2050 received FDA 510(k) clearance on 2018-06-22, under 510(k) number K172586.

Who is the listed applicant for Vios Monitoring System™ Model 2050?

The FDA 510(k) record lists Vios Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vios Monitoring System™ Model 2050?

The FDA product code for Vios Monitoring System™ Model 2050 is DRT.

Other records listing Vios Medical, Inc. 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.

K173107Vios Central Station Monitor Software, Vios Central Server Software

Related Devices (Code: DRT)

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.

K261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, Ltd.K232354Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server SoftwareMurata Vios, Inc.

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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