FUKUDA DENSHI DYNASCOPE MODEL DS-5700— 510(k) K020084

Substantially Equivalent

Fukuda Denshi USA, Inc.

FDA 510(k) clearance K020084 for FUKUDA DENSHI DYNASCOPE MODEL DS-5700, Substantially Equivalent on 2002-02-06. Applicant: Fukuda Denshi USA, Inc..

Clearance details

Applicant: Fukuda Denshi USA, Inc.
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 2002-01-10
Decision date: 2002-02-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

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.