FDA 510(k)

IQvitals Zone

K-Number: K161909 · 2016-11-17

Decision Date2016-11-17

Product CodeMWI

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

IQvitals Zone is a medical device manufactured by Midmark Corporation. It received FDA 510(k) clearance on 2016-11-17 under approval number K161909. 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 IQvitals Zone?

IQvitals Zone is a medical device that received FDA 510(k) clearance on 2016-11-17. It is manufactured by Midmark Corporation. The 510(k) number is K161909.

When was IQvitals Zone approved by the FDA?

IQvitals Zone received FDA 510(k) clearance on 2016-11-17, under approval number K161909.

What company makes IQvitals Zone?

IQvitals Zone is manufactured by Midmark Corporation.

What is the FDA product code for IQvitals Zone?

The FDA product code for IQvitals Zone is MWI.

Other Devices by Midmark Corporation

K163337Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer K201667Midmark Extraoral Imaging System (EOIS) K233026Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer K251626Midmark Dental Delivery System

Related Devices (Code: MWI)

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 K153079Axeo 3 Patient MonitorAxeo Medical Technologies, LLC

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.