FUKUDA DENSHI MODEL HJ-310— 510(k) K901889

Substantially Equivalent

Fukuda Denshi USA, Inc.

FDA 510(k) clearance K901889 for FUKUDA DENSHI MODEL HJ-310, Substantially Equivalent on 1990-07-17. Applicant: Fukuda Denshi USA, Inc..

Clearance details

Applicant: Fukuda Denshi USA, Inc.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 1990-04-26
Decision date: 1990-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

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.