HL-300 RECEIVER MODULE— 510(k) K915879

Substantially Equivalent

Fukuda Denshi USA, Inc.

FDA 510(k) clearance K915879 for HL-300 RECEIVER MODULE, Substantially Equivalent on 1992-01-27. Applicant: Fukuda Denshi USA, Inc..

Clearance details

Applicant: Fukuda Denshi USA, Inc.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 1991-12-30
Decision date: 1992-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.