NEO NEST— 510(k) K112547

Name: FDA 510(k) clearance K112547
Creator: U.S. Food and Drug Administration
Published: 2012-03-06

Substantially Equivalent

Denovo Proucts, LLC

FDA 510(k) clearance K112547 for NEO NEST, Substantially Equivalent on 2012-03-06. Applicant: Denovo Proucts, LLC. Device class: 1.

Clearance details

Applicant: Denovo Proucts, LLC
Product code: Code IMD
Device class: Class 1
Regulation: 21 CFR 890.5710
Advisory panel: Physical Medicine
Date received: 2011-09-01
Decision date: 2012-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ft. Myers, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IMD

product code IMD

Death: 3
Injury: 600
Total: 603

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.