OLYMPUS BF TYPE UM40— 510(k) K021204

Substantially Equivalent

Olympus Optical Co., Ltd.

FDA 510(k) clearance K021204 for OLYMPUS BF TYPE UM40, Substantially Equivalent on 2002-05-01. Applicant: Olympus Optical Co., Ltd..

Clearance details

Applicant: Olympus Optical Co., Ltd.
Product code: Code PSV
Advisory panel: Radiology
Date received: 2002-04-16
Decision date: 2002-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melville, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PSV

product code PSV

Death: 6
Injury: 305
Malfunction: 3,705
Total: 4,016

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.