Cleared Traditional

IQvitals Zone

K161909 · Midmark Corporation · Cardiovascular

Nov 2016

Decision

128d

Days

Class 2

Risk

About This 510(k) Submission

K161909 is an FDA 510(k) clearance for the IQvitals Zone, a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MWI), submitted by Midmark Corporation (Torrance, US). The FDA issued a Cleared decision on November 17, 2016, 128 days after receiving the submission on July 12, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K161909 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 12, 2016
Decision Date	November 17, 2016
Days to Decision	128 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	MWI — Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.2300