ERG 550 ERGOMETER BICYCLE— 510(k) K854491

Substantially Equivalent

Robert Bosch Corp.

FDA 510(k) clearance K854491 for ERG 550 ERGOMETER BICYCLE, Substantially Equivalent on 1986-06-16. Applicant: Robert Bosch Corp..

Clearance details

Applicant: Robert Bosch Corp.
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 1985-11-12
Decision date: 1986-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. James, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.