IQvitals Zone— 510(k) K161909

Name: FDA 510(k) clearance K161909
Creator: U.S. Food and Drug Administration
Published: 2016-11-17

Substantially Equivalent

Midmark Corporation

FDA 510(k) clearance K161909 for IQvitals Zone, Substantially Equivalent on 2016-11-17. Applicant: Midmark Corporation. Device class: 2.

Clearance details

Applicant: Midmark Corporation
Product code: Code MWI
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2016-07-12
Decision date: 2016-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Torrance, CA, US

Download summary PDF View on FDA.gov ↗

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K253436 — c-med0 alpha2026-04-30
K250135 — WAVE Clinical Platform (2.0.000)2026-01-16

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Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.