Vios Monitoring System

FDA 510(k) K150992 · Vios Medical, Inc.

Substantially Equivalent

510(k) numberK150992

Submission

Device name
Vios Monitoring System
Applicant
Vios Medical, Inc.
St. Paul, MN, US
Received
April 15, 2015
Decision date
December 16, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2300
Specialty
Cardiovascular

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K223163Sleepiz One+DRT · Traditional Sleepiz AG08/18/2023SE
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K202138Cardiac Trigger MonitorDRT · Traditional Ivy Biomedical Systems, Inc.05/14/2021SE

More from Ivy Biomedical Systems, Inc.

510(k)DeviceDecision
K173107Vios Central Station Monitor Software, Vios Central Server SoftwareDXJ · Traditional 07/26/2018SE
K172586Vios Monitoring System™ Model 2050DRT · Traditional 06/22/2018SE

Questions and answers

When was Vios Monitoring System cleared by the FDA?

Vios Monitoring System (K150992) received a 510(k) decision of Substantially Equivalent on December 16, 2015, 245 days after the submission was received.

What is the product code of K150992?

The FDA product code is DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), a Class II (moderate risk) device regulated under 21 CFR 870.2300.