Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm— 510(k) K173709

Name: FDA 510(k) clearance K173709
Creator: U.S. Food and Drug Administration
Published: 2018-01-26

Substantially Equivalent

Inneuroco, Inc.

FDA 510(k) clearance K173709 for Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm, Substantially Equivalent on 2018-01-26. Applicant: Inneuroco, Inc.. Device class: 2.

Clearance details

Applicant: Inneuroco, Inc.
Product code: Code DQY
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2017-12-04
Decision date: 2018-01-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Sunrise, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.