CRM-100 COLOR VIDEO CAMERA— 510(k) K831412

Name: FDA 510(k) clearance K831412
Creator: U.S. Food and Drug Administration
Published: 1983-06-03

Substantially Equivalent

Umi, Inc.

FDA 510(k) clearance K831412 for CRM-100 COLOR VIDEO CAMERA, Substantially Equivalent on 1983-06-03. Applicant: Umi, Inc.. Device class: 2.

Clearance details

Applicant: Umi, Inc.
Product code: Code FET
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1983-05-02
Decision date: 1983-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FET

product code FET

Injury: 313
Malfunction: 54,276
Total: 54,589

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.