Cadwell Bolt Software— 510(k) K190760

Name: FDA 510(k) clearance K190760
Creator: U.S. Food and Drug Administration
Published: 2019-11-23

Substantially Equivalent

Cadwell Industries, Inc.

FDA 510(k) clearance K190760 for Cadwell Bolt Software, Substantially Equivalent on 2019-11-23. Applicant: Cadwell Industries, Inc.. Device class: 2.

Clearance details

Applicant: Cadwell Industries, Inc.
Product code: Code OLT
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2019-03-25
Decision date: 2019-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kennewick, WA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OLT

product code OLT

Other: 1
Total: 1

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.