BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM— 510(k) K040940

Substantially Equivalent

Olympus Corporation

FDA 510(k) clearance K040940 for BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM, Substantially Equivalent on 2004-04-19. Applicant: Olympus Corporation.

Clearance details

Applicant: Olympus Corporation
Product code: Code EOQ
Advisory panel: Ear, Nose, Throat
Date received: 2004-04-12
Decision date: 2004-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melville, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EOQ

product code EOQ

Death: 135
Injury: 2,863
Malfunction: 21,662
Total: 24,660

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.