OEC 901— 510(k) K942841

Name: FDA 510(k) clearance K942841
Creator: U.S. Food and Drug Administration
Published: 1994-08-09

Substantially Equivalent

Baldwin

FDA 510(k) clearance K942841 for OEC 901, Substantially Equivalent on 1994-08-09. Applicant: Baldwin. Device class: 2.

Clearance details

Applicant: Baldwin
Product code: Code JAA
Device class: Class 2
Regulation: 21 CFR 892.1650
Advisory panel: Radiology
Date received: 1994-06-16
Decision date: 1994-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JAA

product code JAA

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.