EPM-3300 VIDEO PROCESSOR— 510(k) K934918

Name: FDA 510(k) clearance K934918
Creator: U.S. Food and Drug Administration
Published: 1994-02-07

Substantially Equivalent

Pentax Precision Instrument Corp.

FDA 510(k) clearance K934918 for EPM-3300 VIDEO PROCESSOR, Substantially Equivalent on 1994-02-07. Applicant: Pentax Precision Instrument Corp.. Device class: 2.

Clearance details

Applicant: Pentax Precision Instrument Corp.
Product code: Code FET
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1993-10-15
Decision date: 1994-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orangeburg, NY, 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.